Exforge

Nephrotic Syndrome, Ascites, Edema + 23 more

Treatment

30 FDA approvals

20 Active Studies for Exforge

What is Exforge

Hydrochlorothiazide

The Generic name of this drug

Treatment Summary

Amlodipine is a medication used to treat high blood pressure and chest pain (angina). It belongs to a class of drugs called dihydropyridine calcium channel blockers which are known to have fewer side effects than other types of blood pressure medications. Amlodipine works by widening your blood vessels, reducing the pressure in your blood vessels, and increasing the production of a compound called nitric oxide which helps to lower blood pressure. This medication was first approved by the FDA in 1987 and can be taken once daily.

Esidrix

is the brand name

image of different drug pills on a surface

Exforge Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Esidrix

Hydrochlorothiazide

1959

2181

Approved as Treatment by the FDA

Hydrochlorothiazide, also called Esidrix, is approved by the FDA for 30 uses including calcium channel blockers and inadequate response to other therapeutic measures .

calcium channel blockers

Used to treat calcium channel blockers in combination with Eprosartan

inadequate response to other therapeutic measures

Used to treat inadequate response to other therapeutic measures in combination with Spironolactone

Premenstrual tension with edema

Helps manage Premenstrual tension with edema

Left Ventricular Hypertrophy

Used to treat Left Ventricular Hypertrophy in combination with Losartan

Hypertension

Used to treat Antihypertensive Treatment in combination with Eprosartan

Hypertension

Used to treat blood pressure inadequately controlled with monotherapy in combination with Irbesartan

prophylaxis of preeclampsia

Helps manage prophylaxis of preeclampsia

Swollen feet or ankles

Used to treat Edema in combination with Triamterene

Hypertension, Essential Hypertension

Used to treat Hypertension, Essential Hypertension in combination with Spironolactone

Congestive Heart Failure

Used to treat Congestive Heart Failure (CHF) in combination with Spironolactone

Diuretics

Used to treat Hypokalemia caused by diuretics in combination with Amiloride

Hypertensive disease

Used to treat Hypertension, Essential Hypertension in combination with Spironolactone

Antepartum magnesium sulfate prophylaxis

Helps manage prophylaxis of preeclampsia

Hypertrophy, Left Ventricular

Used to treat Left Ventricular Hypertrophy in combination with Losartan

Stroke

Used to treat Cerebrovascular Accident in combination with Losartan

Edema

Used to treat Edema in combination with Triamterene

Cirrhosis of the Liver

Used to treat Cirrhosis of the Liver in combination with Spironolactone

Nephrotic Syndrome

Used to treat Nephrotic Syndrome in combination with Spironolactone

Hypertension

Used to treat inadequate control of blood pressure with monotherapy in combination with Aliskiren

Congestive Heart Failure (CHF)

Used to treat Congestive Heart Failure (CHF) in combination with Spironolactone

Hypokalemia

Used to treat hypokalemia with solo treatment in combination with Triamterene

Ascites

Used to treat Ascites in combination with Spironolactone

Therapeutic procedure

Used to treat inadequate response to treatment in combination with Spironolactone

Ascites

Used to treat Ascites in combination with Spironolactone

Hypertensive disease

Used to treat High Blood Pressure (Hypertension) in combination with Losartan

Sodium retention

Used to treat Sodium retention in combination with Spironolactone

Bedrest

Used to treat Bedrest in combination with Spironolactone

Cirrhosis

Used to treat Cirrhosis of the Liver in combination with Spironolactone

restriction of fluid and sodium

Used to treat restriction of fluid and sodium in combination with Spironolactone

Edema

Helps manage Premenstrual tension with edema

Effectiveness

How Exforge Affects Patients

Amlodipine is a drug that attaches to certain cell membranes and slows down the flow of calcium into the cells, resulting in lower blood pressure. Taking amlodipine once a day can maintain the effect for up to 24 hours. It does not usually change heart rate or how electrical signals move through the heart. Amlodipine can help relieve chest pain associated with angina by increasing exercise time, decreasing angina attack frequency, and reducing the need for nitroglycerin tablets.

How Exforge works in the body

Amlodipine is a drug that helps to lower blood pressure by relaxing blood vessels and allowing blood to flow more easily. It does this by blocking calcium from entering the cells in both the heart and the blood vessels. This blockage leads to a decrease in tension and pressure, allowing for easier circulation and a reduction in blood pressure. In addition, Amlodipine helps to reduce angina symptoms by reducing the amount of energy and oxygen needed by the heart, as well as by widening the main coronary arteries and coronary arterioles. This increases oxygen delivery to the heart, reducing pain and discomfort.

When to interrupt dosage

The preferred dosage of Exforge is contingent upon the diagnosed condition, such as inadequate response to diet, High Cardiovascular Risk and Lifestyle Modification. The measure of dosage can be found in the table below, relative to the method of delivery (e.g. Tablet, film coated or Tablet).

Condition

Dosage

Administration

Therapeutic procedure

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Nephrolithiasis

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Hypertension

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Hypertensive disease

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Hypertrophy, Left Ventricular

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Edema

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Sodium retention

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Antepartum magnesium sulfate prophylaxis

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Diabetes Insipidus

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Congestive Heart Failure

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Cirrhosis

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Hypertension

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Hypokalemia

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Hypertension

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Swollen feet or ankles

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Renal tubular acidosis

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

restriction of fluid and sodium

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

calcium channel blockers

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Diuretics

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

prophylaxis of calcium nephrolithiasis

12.5 mg, , 25.0 mg, 50.0 mg, 15.0 mg, 6.25 mg, 0.25 mg, 0.125 mg, 100.0 mg, 2.5 mg/mg, 5.0 mg/mg, 30.0 mg, 0.0125 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, Tablet - Oral, Capsule - Oral, Capsule, Capsule, gelatin coated - Oral, Tablet, coated, Tablet, coated - Oral, Capsule, gelatin coated

Warnings

Exforge has one contraindication and should not be incorporated with the conditions presented in the following table.

Exforge Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Anuria

Do Not Combine

There are 20 known major drug interactions with Exforge.

Common Exforge Drug Interactions

Drug Name

Risk Level

Description

Amifostine

Major

Hydrochlorothiazide may increase the hypotensive activities of Amifostine.

Cyclopentamine

Major

The risk or severity of adverse effects can be increased when Hydrochlorothiazide is combined with Cyclopentamine.

Dofetilide

Major

The risk or severity of QTc prolongation can be increased when Hydrochlorothiazide is combined with Dofetilide.

Fenofibrate

Major

The therapeutic efficacy of Fenofibrate can be decreased when used in combination with Hydrochlorothiazide.

Hydroxyzine

Major

The risk or severity of QTc prolongation can be increased when Hydrochlorothiazide is combined with Hydroxyzine.

Exforge Toxicity & Overdose Risk

The toxic dose of amlodipine in mice is 37mg/kg. An overdose can cause an extreme widening of the blood vessels and a rapid heartbeat. Studies on rats and mice have not found any links to cancer, gene or chromosome damage, or infertility. It is not known if amlodipine is safe for pregnant or breastfeeding women, so use of the drug should be carefully considered. Nursing mothers should stop taking amlodipine before nursing.

image of a doctor in a lab doing drug, clinical research

Exforge Novel Uses: Which Conditions Have a Clinical Trial Featuring Exforge?

46 active clinical trials are currently evaluating the efficacy of Exforge in decreasing High Cardiovascular Risk, alleviating Vasospastic Angina and ameliorating Coronary Artery Disease (CAD).

Condition

Clinical Trials

Trial Phases

Cirrhosis

47 Actively Recruiting

Phase 1, Not Applicable, Phase 3, Phase 2, Phase 4

prophylaxis of calcium nephrolithiasis

0 Actively Recruiting

Antepartum magnesium sulfate prophylaxis

20 Actively Recruiting

Not Applicable, Early Phase 1, Phase 2, Phase 4, Phase 1

Ascites

2 Actively Recruiting

Not Applicable, Phase 2

Sodium retention

0 Actively Recruiting

Swollen feet or ankles

3 Actively Recruiting

Phase 2, Not Applicable

Congestive Heart Failure

13 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Hypertensive disease

30 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3

inadequate response to other therapeutic measures

0 Actively Recruiting

Hypertension

0 Actively Recruiting

Diuretics

0 Actively Recruiting

restriction of fluid and sodium

0 Actively Recruiting

Therapeutic procedure

0 Actively Recruiting

Hypertrophy, Left Ventricular

0 Actively Recruiting

Nephrotic Syndrome

6 Actively Recruiting

Phase 2, Not Applicable, Phase 3

calcium channel blockers

0 Actively Recruiting

Hypokalemia

0 Actively Recruiting

Hypertension

0 Actively Recruiting

Hypertension

0 Actively Recruiting

Bedrest

0 Actively Recruiting

Exforge Reviews: What are patients saying about Exforge?

5

Patient Review

8/14/2014

Exforge for High Blood Pressure

Exforge is an excellent medication, but it can be quite expensive.

5

Patient Review

12/20/2018

Exforge for High Blood Pressure

I've been taking Exforge for ten years now, and it's never given me any problems. My blood pressure has always stayed at a healthy level since I started taking the medication.

5

Patient Review

11/26/2013

Exforge for High Blood Pressure

4.3

Patient Review

5/13/2014

Exforge for High Blood Pressure

I've been taking this medication for four years to help with my blood pressure. While it is effective for that, I have found that it also causes me to feel dizzy and experience muscle cramps on a daily basis.

4.3

Patient Review

2/18/2014

Exforge for High Blood Pressure

I took this drug for two years to help control my blood pressure, but stopped because the pills were too large and started causing me to lose hair.

4

Patient Review

2/6/2022

Exforge for High Blood Pressure

Helped me lower my blood pressure. I have a problem with swelling in my legs and ankles if I sit for too long, but this has alleviated that issue.

3.7

Patient Review

5/6/2014

Exforge for High Blood Pressure

Exforge caused some dangerous side effects for me, including but not limited to irregular heartbeats, fast heartbeat, and swollen extremities. I had to stop using it after a month, and even now (over a month later) I'm still dealing with the permanent swelling. This drug needs to be more heavily regulated.

3.7

Patient Review

6/30/2015

Exforge for High Blood Pressure

I'm feeling better, though there are some side effects like dizziness and swelling. The wheatgrass powder has been helping a lot too.

3.7

Patient Review

5/20/2014

Exforge for High Blood Pressure

While this medication was wonderful in bringing down my blood pressure, the side effects were not worth it. I struggled to breathe normally, and my feet and ankles became so swollen that there was a rash-like redness on both of my legs.

3

Patient Review

4/8/2014

Exforge for High Blood Pressure

While this medication has helped to lower my blood pressure, I have noticed some negative side effects, such as increased hair loss and swelling in my ankles.

2.7

Patient Review

9/15/2014

Exforge for High Blood Pressure

I generally feel weak and sick to my stomach after taking this medication. Additionally, I often have sudden episodes of energy draining from my body at night when I am just lying in bed. When the daily dose wears off, my blood pressure is even higher than before!

2.7

Patient Review

3/28/2014

Exforge for High Blood Pressure

I started having muscular soreness in my upper arms, as well as nausea and vomiting.

2.3

Patient Review

1/8/2014

Exforge for High Blood Pressure

Afternoon headaches; expensive medication.

2.3

Patient Review

3/3/2014

Exforge for High Blood Pressure

Blurred vision and swollen extremities were some of the side effects I experienced. My blood pressure did improve somewhat, but it was still pretty unstable.

2

Patient Review

2/17/2014

Exforge for High Blood Pressure

Though this drug is expensive, I found it didn't help with my cramps at all. In fact, the first night I took it I had such extreme cramps that I couldn't move in bed. Additionally, I experienced daily headaches, dizziness, confusion, and disorientation.

1.7

Patient Review

11/20/2013

Exforge for High Blood Pressure

1.7

Patient Review

10/14/2014

Exforge for High Blood Pressure

I had to stop taking this medication after only two weeks due to the severe dizziness and swollen feet it caused me. Unfortunately, my feet still have not returned to normal.

1.3

Patient Review

11/20/2013

Exforge for High Blood Pressure

1

Patient Review

4/3/2014

Exforge for High Blood Pressure

I found that I was actually healthier when I stopped taking FORGE. I experienced side effects like a racing heartbeat, itchiness all over my body, and dizziness/collapse/passing out feelings. My blood pressure is normal without medication now. If my systolic moves up, I will take Metoprolol 12.5mg daily; which is also effective for my lifelong infrequent daily skipping heartbeats.

1

Patient Review

1/28/2019

Exforge for High Blood Pressure

I was prescribed this medication yesterday, but after reading all of the reviews online, I'm terrified to take it. The side effects people have experienced sound absolutely awful. Has anyone had any success with this medication? Or do the side effects continue even after taking it for a while?
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about exforge

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Exforge good for kidney?

"Exforge is designed to be gentle on the kidneys, but in some cases it may have the opposite effect. Therefore, regular checkups are important to monitor kidney function before and during treatment."

Answered by AI

What are the side effects of Exforge?

"You may experience dizziness, headaches, or fatigue along with nausea and an upset stomach. A stuffy nose, sinus pain, or sore throat are also common. You may also experience back pain or muscle spasms. Finally, you may notice swelling in your hands, ankles, or feet."

Answered by AI

Is Exforge safe to take?

"Exforge may rarely cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. If you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever, unusual tiredness, and dark colored urine, call your doctor right away."

Answered by AI

What is the medication Exforge used for?

"This product is used to lower high blood pressure, which can prevent strokes, heart attacks, and kidney problems. It contains two medications, amlodipine and valsartan, which both work by relaxing blood vessels to allow blood to flow more easily."

Answered by AI

Clinical Trials for Exforge

Image of University of California, San Diego in San Diego, United States.

BPCARE Intervention for High Blood Pressure

18+
All Sexes
San Diego, CA

The goal of this randomized clinical trial is to determine whether a community health worker-delivered, multi-component behavioral intervention can improve antihypertensive medication adherence and blood pressure control among adult refugees with hypertension who are prescribed antihypertensive medications. The main questions it aims to answer are: 1. Does participation in the BPCARE intervention improve antihypertensive medication adherence compared to enhanced usual care? 2. Does participation in the BPCARE intervention improve blood pressure control and persistence over time compared to enhanced usual care? Researchers will compare participants randomized to the BPCARE intervention to those receiving enhanced usual care (hypertension information and a home blood pressure monitor) to determine the effects on medication adherence, blood pressure control, and persistence. Participants will: * Be randomly assigned to either the BPCARE intervention or enhanced usual care * Receive hypertension education and a home blood pressure monitor * Participate in community health worker-delivered sessions that include hypertension and medication education, motivational interviewing, problem-solving, and action planning (intervention arm only) * Complete questionnaires assessing medication adherence and related psychosocial factors * Have blood pressure monitored using connected home blood pressure devices * Complete pill counts to assess medication adherence over a nine-month follow-up period

Recruiting
Has No Placebo

University of California, San Diego (+1 Sites)

Image of National Association of Pasifika Organizations in Fayetteville, United States.

PILI Pasifika Program for Cardiometabolic Conditions

18+
All Sexes
Fayetteville, AR

In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) Standard Facilitation or Enhanced Facilitation across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 600 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The investigators will conduct an effectiveness-implementation hybrid type 2 trial using a 3 (Region) x 2 (Setting) x 2 (Delivery Mode) factorial design. The long-term objective of this study is threefold: 1. To conduct an effectiveness-implementation hybrid 2 trial to test the effects of the PPP implementation strategies across different settings and modes of delivery among 600 NHPIs at risk for cardiometabolic-related conditions using an NHPI-approved and adapted evaluation framework. The investigators will also assess and compare the cost-effectiveness of the CHW-delivered PPP-Standard Facilitation and PPP-Enhanced Facilitation to support long-term sustainability. 2. To conduct a longitudinal Social Determinants of Health (SDOH) survey embedded within the trial to examine the reliability and validity of indices from 5 adapted SDOH instruments and to assess the associations between SDOH variables and chronic disease risk among NHPIs. 3. To implement and evaluate the contextually-based CHW training program on PPP delivery.

Waitlist Available
Has No Placebo

National Association of Pasifika Organizations (+1 Sites)

Joseph K Kaholokula, PhD

Image of Rush University Medical Center in Chicago, United States.

Food is Medicine for High Blood Pressure

18+
All Sexes
Chicago, IL

The goal of this clinical trial is to assess nutrition incentives and produce vouchers to measure the impacts of food insecurity-related chronic health conditions in adults with hypertension and/or diabetes. The main questions it aims to answer are: * Does participation increase fruit and vegetable consumption for participants? * Does participation reduce individual and household food insecurity? * Does participation reduce healthcare utilization and associated costs? * Does participation lead to improvements in diet-related health outcomes (e.g., hypertension, diabetes)? * Does participation support the local economy by increasing participant spending at local food vendors? Participants will: * Receive 6 months home delivered produce prescription boxes * Receive 6 months match of produce vouchers * Receive nutrition education and participate in Chronic Disease Self-Management classes

Waitlist Available
Has No Placebo

Rush University Medical Center

Traci Simmons, DrPHc, MPH

Have you considered Exforge clinical trials?

We made a collection of clinical trials featuring Exforge, we think they might fit your search criteria.
Go to Trials
Image of Miles Square Health Center Chicago in Chicago, United States.

Food is Medicine for High Blood Pressure and Obesity

Any Age
All Sexes
Chicago, IL

The goal of this clinical trial is to treat both hypertension and obesity in adults using a food is medicine framework. Participants will be randomized 1:1 to FIM+DASH or usual-care control. The 24-week trial includes a 12-week FIM+DASH intervention followed by a 12-week maintenance period and leverages existing partnerships with community-based organizations for home food delivery and culinary skill-skill building. The main questions it aims to answer are: (1) What is the effect of FIM+DASH vs. usual care control on blood pressure? (2) What is the effect of FIM+DASH vs. usual care control on DASH diet adherence (diet quality), body weight, and waist circumference? (3) How to identify factors associated with the sustainability and scalability of FIM+DASH in real-world settings?

Phase 2
Waitlist Available

Miles Square Health Center Chicago (+3 Sites)

Image of Mumford Professional Centre in Halifax, Canada.

Remote Monitoring for Cardiovascular Disease

18+
All Sexes
Halifax, Canada

The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. The question guiding this study is: Do patient clinical outcomes differ between those who use the CardioWatch 287-2 during the HEARTS in Sync program as compared to those who participate without using the CardioWatch 287-2? The comparison will happen between two non-randomized groups of patients who are enrolled in the HEARTS in Sync virtual CR program. The wearable device (CardioWatch 287-2), worn on patient's wrists, will provide clinicians with physiological information to better mirror the clinical oversight provided to an in-person CR program. Participants who choose to use the device will be asked to wear it daily. The clinical team will review weekly summary reports to help guide participant progress through the 13-week program. The primary objectives of this study are to: 1. Characterize participants (e.g., demographic health history, patient feedback) between those who choose to use the CardioWatch 287-2 device and those who do not. 2. Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by: 1. Tracking patient enrollment, attendance in virtual education sessions, and program completion rates, 2. Evaluating change in patient bloodwork outcomes, 3. Measuring change is physical ability, 4. Analyzing changes in eating behaviours, and 5. Examining quality of life using validated tools. 3. Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by: 1. Assessing device adherence 2. Reviewing patient feedback survey, and 3. Determining if clinician team were able to access and interpret data collected throughout the program The secondary objective of this study is to compare clinical outcomes of device users during the HEARTS in Sync program with patients who completed the on-site CR program. This research aims to better understand how a medical-grade device may improve virtual CR programming to extend clinical care to the community. As a result, this could lead to a more personalized care and better results for patients.

Waitlist Available
Has No Placebo

Mumford Professional Centre

Nicholas B Giacomantonio, Medical Doctor

Corsano Health B.V.

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Meal Macronutrients for Blood Fat Levels

18 - 120
All Sexes
Bethesda, MD

Background: Abnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome. Objective: To learn more about how different types of foods affect fat levels in the blood. Eligibility: People aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed. Design: Participants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal. Participants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after. Participants will have other tests during their stays: * A resting metabolic test captures the air they exhale and measures how much energy they use at rest. * A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have. * A Fibroscan is a special type of ultrasound of the liver. * A body surface scan uses lasers to measure the total area of the body. * A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body. Participants may opt to have a third visit. At this visit, the breakfast will be high in protein.

Phase 2
Waitlist Available

National Institutes of Health Clinical Center

Rebecca J Brown, M.D.

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Minocycline for Stroke

18+
All Sexes
Brooklyn, NY

The goal of this study is to determine if Minocycline, when added to standard care, can improve survival and functional outcomes in patients with moderate acute stroke (ischemic or hemorrhagic) aged 18 years and older. The main questions it aims to answer are: 1. Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke? 2. Does Minocycline reduce stroke-related disability, all-cause in hospital mortality (mRS -\*Modified Rankin Scale\* = 6) and at 90 days besides reducing brain bleeding complications compared to standard care? Researchers will compare patients receiving oral Minocycline plus standard care to those receiving standard care only to see if Minocycline leads to better neurological outcomes and lower mortality. Participants will: 1. Be randomly assigned by block to receive either: Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset + Standard Care, or Standard Care only 2. Undergo neurological assessments using NIHSS \*National Institutes of Health Stroke Scale\* and Modified Rankin Scale (mRS) at admission, discharge, 30 days post-stroke, 90 days post-stroke 3. Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses NIHSS: \*National Institutes of Health Stroke Scale\*, which is stroke severity scale, mRS: \*Modified Rankin Scale\*, which is stroke disability scale

Phase 2 & 3
Recruiting

Maimonides Medical Center

Qingliang T. Wang, MD, PhD

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