Aldactazide

Nephrotic Syndrome, Ascites, Hypokalemia + 14 more

Treatment

18 FDA approvals

20 Active Studies for Aldactazide

What is Aldactazide

Spironolactone

The Generic name of this drug

Treatment Summary

Spironolactone is a medication used to treat a range of medical conditions, including heart failure, high blood pressure, and nephrotic syndrome. It works by blocking certain hormones in the body, which helps regulate sodium and water levels in the body. It can also be used off-label to treat hirsutism, female pattern hair loss, adult acne, and as part of medical gender transition. Spironolactone was approved by the FDA in 1960.

Spironolactone

is the brand name

Aldactazide Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Spironolactone

Spironolactone

1960

288

Approved as Treatment by the FDA

Spironolactone, also known as Spironolactone, is approved by the FDA for 18 uses such as Primary Hyperaldosteronism and Swollen feet or ankles .

Primary Hyperaldosteronism

Helps manage Primary Hyperaldosteronism

Swollen feet or ankles

Helps manage Edema

Ascites

Helps manage Ascites

Hypokalemia

chronic heart failure with reduced ejection fraction (NYHA Class IV)

Helps manage chronic heart failure with reduced ejection fraction (NYHA Class IV)

Cirrhosis of the Liver

Helps manage Cirrhosis of the Liver

idiopathic hyperaldosteronism

Helps manage idiopathic hyperaldosteronism

Congestive Heart Failure (CHF)

Helps manage Congestive Heart Failure (CHF)

Hypesthesia

Helps manage chronic heart failure with reduced ejection fraction (NYHA Class IV)

Edema

Helps manage Edema

Hypesthesia

Helps manage chronic heart failure with reduced ejection fraction (NYHA Class III)

Cirrhosis

Helps manage Cirrhosis of the Liver

Hyperaldosteronism

Helps manage Primary Hyperaldosteronism

Nephrotic Syndrome

Helps manage Nephrotic Syndrome

Congestive Heart Failure

Helps manage Congestive Heart Failure (CHF)

Hypertensive disease

Helps manage High Blood Pressure (Hypertension)

Ascites

Helps manage Ascites

Hyperaldosteronism

Helps manage idiopathic hyperaldosteronism

Effectiveness

How Aldactazide Affects Patients

Spironolactone is a drug that helps the body get rid of extra water and salt while still keeping potassium. It blocks the hormone receptors in the kidneys that control sodium and water levels, leading to higher levels of renin and aldosterone. This drug is similar to the female hormone progesterone, and can cause some progestogenic and antiandrogenic effects.

How Aldactazide works in the body

Spironolactone helps reduce water retention in the body and lower blood pressure. It does this by blocking channels that allow sodium and potassium to be exchanged in the kidneys, leading to increased sodium and water excretion and more potassium retained in the body.

When to interrupt dosage

The measure of Aldactazide is contingent upon the determined malady, including Hypesthesia, Congestive Heart Failure and Cirrhosis. The quantity of dosage fluctuates according to the method of delivery outlined in the table beneath.

Condition

Dosage

Administration

Nephrotic Syndrome

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Ascites

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hypokalemia

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Acne Vulgaris

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hyperaldosteronism

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hyperaldosteronism

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Swollen feet or ankles

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hypesthesia

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hypesthesia

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Congestive Heart Failure

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hirsutism

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hypertensive disease

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hyperaldosteronism

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Cirrhosis

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Edema

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Hypertension

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

inadequate response to other therapeutic measures

50.0 mg, , 100.0 mg, 25.0 mg, 25.0 mg/mL, 0.02 mg/mg, 0.05 mg/mg

, Tablet, film coated, Tablet, film coated - Oral, Oral, Tablet, Tablet - Oral, Suspension, Suspension - Oral, Gel - Topical, Gel, Topical, Tablet, coated - Oral, Tablet, coated

Warnings

Aldactazide has six contraindications, so it should not be employed in cases of the conditions given in the following table.

Aldactazide Contraindications

Condition

Risk Level

Notes

Renal Insufficiency

Do Not Combine

Anuria

Do Not Combine

Acute Kidney Injury

Do Not Combine

Hyperkalemia

Do Not Combine

Pulse Frequency

Do Not Combine

Addison Disease

Do Not Combine

There are 20 known major drug interactions with Aldactazide.

Common Aldactazide Drug Interactions

Drug Name

Risk Level

Description

Amiodarone

Major

The metabolism of Amiodarone can be decreased when combined with Spironolactone.

Brigatinib

Major

The metabolism of Brigatinib can be decreased when combined with Spironolactone.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Spironolactone.

Cyclosporine

Major

The risk or severity of hyperkalemia can be increased when Spironolactone is combined with Cyclosporine.

Dabrafenib

Major

The metabolism of Dabrafenib can be decreased when combined with Spironolactone.

Aldactazide Toxicity & Overdose Risk

Symptoms of spironolactone overdose may include drowsiness, confusion, rash, nausea, vomiting, dizziness, or diarrhea. Treating an overdose may involve keeping the patient hydrated, maintaining electrolyte balance, and monitoring vital functions. The highest toxic dose in mice, rats, and rabbits has been found to be greater than 1g/kg. Spironolactone should not be taken during pregnancy as it has been linked to male fetus feminization in animal studies. Breastfeeding mothers should also avoid this drug as it can be passed through breast milk, though no long-term side effects have been studied. Animal studies

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

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

165 active studies are currently being conducted to evaluate the potential of Aldactazide to alleviate Hypokalemia, Hirsutism and Nephrotic Syndrome.

Condition

Clinical Trials

Trial Phases

Hypesthesia

8 Actively Recruiting

Not Applicable, Phase 1

Cirrhosis

49 Actively Recruiting

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

Ascites

2 Actively Recruiting

Not Applicable, Phase 2

Nephrotic Syndrome

6 Actively Recruiting

Phase 2, Not Applicable, Phase 3

Hypertension

0 Actively Recruiting

Congestive Heart Failure

12 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Hirsutism

0 Actively Recruiting

Hypokalemia

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Hyperaldosteronism

0 Actively Recruiting

inadequate response to other therapeutic measures

0 Actively Recruiting

Hyperaldosteronism

0 Actively Recruiting

Hypertensive disease

27 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3

Swollen feet or ankles

4 Actively Recruiting

Phase 2, Not Applicable, Phase 4

Hypesthesia

5 Actively Recruiting

Not Applicable, Phase 1

Hyperaldosteronism

0 Actively Recruiting

Edema

0 Actively Recruiting

Aldactazide Reviews: What are patients saying about Aldactazide?

5

Patient Review

7/7/2009

Aldactazide for High Blood Pressure

The tablets are a bit large, but they're easy to swallow.

4.3

Patient Review

11/22/2017

Aldactazide for High Blood Pressure

I unfortunately experienced some intense breast pain while taking this medication.

4

Patient Review

2/10/2013

Aldactazide for High Blood Pressure

I was on this medication for a couple years, but I started having stomach pains, dizziness, nausea, sugar elevation, and muscle and joint pain. So I stopped taking it without consulting my doctor first. After only one week off the meds, my joints are almost pain free!

3

Patient Review

1/20/2011

Aldactazide for High Blood Pressure

I'm still testing this out to see if there are any negative side effects. So far, so good!

2.7

Patient Review

2/24/2014

Aldactazide for High Blood Pressure

My blood pressure has gone down since taking this medication, but my blood sugar and weight have increased. I've been told that I need to lose weight as a result, and now I'm considered borderline diabetic.

2.3

Patient Review

10/22/2007

Aldactazide for High Blood Pressure

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about aldactazide

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

Why is Aldactazide a hazardous drug?

"Hydrochlorothiazide may cause low potassium and sodium levels. The risk of low potassium may be increased in patients with cirrhosis, excessive urination, or with the concurrent use of drugs that lower potassium levels."

Answered by AI

What is the drug Aldactazide used for?

"This product is used to treat high blood pressure (hypertension), heart failure, or extra fluid in the body (edema). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems."

Answered by AI

Can Aldactazide cause low potassium?

"If you have low potassium levels, you may experience leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness, or a limp feeling."

Answered by AI

Is Aldactazide the same as spironolactone?

"Aldactazide is a diuretic that is used to treat heart failure, high blood pressure, and swelling due to certain liver or kidney problems. It is a 2-in-1 diuretic that combines two diuretics into a single pill for convenience."

Answered by AI

Clinical Trials for Aldactazide

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.

Image of National Institutes of Health Clinical Center in Bethesda, United States.

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.

Image of U Health in Miami, United States.

Cuffless PPG Monitor for High Blood Pressure

18+
All Sexes
Miami, FL

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Waitlist Available
Has No Placebo

U Health (+1 Sites)

Ziad Zoghby, M.D., M.B.A.

Biobeat Technologies Ltd.

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Image of Cedars-Sinai Medical Center in Los Angeles, United States.

AI-Enabled Identification for Fatty Liver Disease

18+
All Sexes
Los Angeles, CA

The goal of this prospective, multicenter, open-label, blinded end-point pragmatic study is to evaluate an artificial intelligence (AI)-augmented echocardiography screening approach for early detection of metabolic dysfunction associated steatotic liver disease (MASLD) and/or cirrhosis, in patients undergoing routine transthoracic echocardiograms (TTEs). The main question it aims to answer is to: 1. Evaluate notification responsiveness and rates of confirmatory testing for patients identified as high risk for having liver disease to determine whether optimized notifications increase timely confirmatory testing and treatment initiation versus standard of care assessment. 2. Compare time to diagnosis, treatment uptake, and clinical outcomes (hospitalizations, incident ASCVD, mortality) between cohorts identified as high risk by the AI algorithm and comparison groups to determine whether AI guided screening shortens time to diagnosis and increases appropriate treatment.

Waitlist Available
Has No Placebo

Cedars-Sinai Medical Center (+3 Sites)

Image of University of Alabama at Birmingham in Birmingham, United States.

Dietary Interventions for Hypertension

18+
All Sexes
Birmingham, AL

Natriuretic peptides (NPs) are hormones produced by the heart and play an important role in maintaining cardiovascular health and have favorable metabolic benefits. Low NP levels are associated with an increased likelihood of the development of cardiometabolic diseases like diabetes and hypertension. NP levels are known to be highly heritable, with up to half of the differences in NP levels being explained by genetics. The investigators aim to describe the genetic architecture of NPs by examining the genetic variants associated with NPs, and generate and validate a polygenic score (PGS) for NPs. The investigators will use this NP PGS to examine the association of genetically determined NP levels with cardiometabolic and cardiovascular outcomes. The investigators will conduct a genotype-guided physiological clinical trial that aims to assess the genetic factors affecting NP levels and their impact on blood pressure and NP response to saline infusion, high-salt diet, and low-salt diet. These findings will help support personal medicine approaches to lower the increasing burden of hypertension in the United States.

Waitlist Available
Has No Placebo

University of Alabama at Birmingham

Pankaj Arora, MD, FAHA

Image of Cleveland Clinic Main Campus in Cleveland, United States.

Metabolic Surgery and TIPS for Liver Cirrhosis

18 - 70
All Sexes
Cleveland, OH

Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present. This study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes. The study will compare two groups: 1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG). 2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications). All participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups. The main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment. Participants will be followed for 6 months after their treatment starts, with periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes. This study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.

Phase 4
Recruiting

Cleveland Clinic Main Campus

Sobia Laique, MD

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Image of Virginia Commonwealth University in Richmond, United States.

Endovascular Treatment for Stroke

18+
All Sexes
Richmond, VA

Endovascular therapy (EVT) has proven to be more beneficial for patients with AIS caused by large vessel occlusions (LVO) than medical management alone. A recent meta-analysis of 5 RCTs showed that EVT significantly reduced disability at 90 days compared to medical management \[1\]. Despite its obvious benefits, patients may have neurological deterioration despite successful thrombectomy due to ischemia progression, intracranial hemorrhage, re-occlusion, or vasogenic edema. The incidence of early neurological deterioration (END) following EVT for acute stroke has been reported to be ranging from 14.1-35.2% with some studies defining END up to 7 days and some restricting the definition between 6-72 hours post thrombectomy. A small proportion of these patients, approximately 5.9-10.5%, experienced sICH following EVT. Whether END occurs due to ischemic or hemorrhagic it leads to worse outcomes.

Waitlist Available
Has No Placebo

Virginia Commonwealth University

Aarti Sarwal

Image of Future Life Clinical Trials in Miami, United States.

Extended vs Immediate Release Torsemide for Heart Failure

18+
All Sexes
Miami, FL

The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. During the study period, participants' current loop diuretics will be replaced with an equivalent dose of either immediate-release or extended-release torsemide. Following a one-week stabilization period on the assigned torsemide formulation, patients will report to the clinical site for an assessment visit. On the study day, patients will take a single dose of the same torsemide formulation they have been on for the past week, administered after breakfast. Urine samples be collected are: * 0-4 hours post-dosing (pre-lunch period) * 4-8 hours post-dosing (post-lunch period) * 8-24 hours post-dosing (24 hours period) The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.

Phase 4
Recruiting

Future Life Clinical Trials

Salim Shah, PhD, JD

Sarfez Pharmaceuticals, Inc.

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