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Cardiovascular Agent
Polypill for Heart Failure
Phase < 1
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
New York Heart Association class II, III, or IV symptoms
HF with left ventricular ejection fraction <= 40% within 3 months of screening who are not on optimal guideline directed medical therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 month, 6 month
Awards & highlights
Study Summary
This trial is testing whether an inexpensive once-daily pill containing three agents proven to improve morbidity and mortality in heart failure is effective in a low-income, racially diverse population.
Who is the study for?
This trial is for adults over 18 with heart failure and a reduced ejection fraction (HFrEF), specifically those not already on the best standard treatments. It's aimed at helping low-income, racially diverse populations. People can't join if they're pregnant, have severe blood pressure issues, recent revascularization, type 1 diabetes, allergies to certain heart medications, extremely high creatinine or potassium levels in their blood, need for constant heart support drugs, very low cardiac output or are severely obese.Check my eligibility
What is being tested?
The study is testing a 'polypill'—a single pill containing three medications that improve outcomes in heart failure patients—against usual care without the polypill. The goal is to see if this approach works well in a practical setting among people of different races and lower socioeconomic status.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from the medications in the polypill could include dizziness due to low blood pressure; kidney function changes; increased potassium levels which can affect your heartbeat; and possible allergic reactions if sensitive to any of its components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe heart condition symptoms.
Select...
My heart's pumping ability is reduced and I'm not on the best treatment plan yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 month, 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 month, 6 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Left ventricular ejection fraction
Secondary outcome measures
HF hospitalization rate
Kansas City Cardiomyopathy Questionnaire Quality of Life
LVEF through echocardiography
+3 moreSide effects data
From 2008 Phase 2 trial • 475 Patients • NCT006035901%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polypill
Control
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Polypill ArmExperimental Treatment1 Intervention
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include metoprolol succinate (a beta-blocker), empagliflozin (an SGLT2-inhibitor), and spironolactone (a mineralocorticoid antagonist). Three dose formulations of the pill, varied in metoprolol succinate dose, will be available for up-titration of the beta-blocker dose per ACC/AHA/HFSA guidelines.
Group II: Control ArmActive Control1 Intervention
Patients will receive GDMT as usually prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polypill
2011
Completed Phase 3
~2880
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,636 Total Patients Enrolled
23 Trials studying Heart Failure
13,164 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is below 110 mm Hg and I'm not on blood pressure medication.My kidney function test shows creatinine above 2.5 (men) or 2.0 (women).I have moderate to severe heart condition symptoms.I have ongoing or permanent irregular heartbeats and may not be suitable for MRI scans.You have a heart device that cannot be used during an MRI.My heart's pumping ability is reduced and I'm not on the best treatment plan yet.I have type 1 diabetes.I cannot take certain medications due to adverse reactions.Your blood potassium level is higher than 5.0 mEq/L.I am allergic to or cannot take certain heart or diabetes medications.My BMI is over 45.I currently need medication to help my heart pump more effectively.I have had or am planning to have a procedure to improve blood flow within the last 30 days.I am 18 years old or older.You are not expected to live for more than 12 months.I am under 18 years old.My blood pressure is below 100 mm Hg while on medication for hypertension.Your heart is not pumping enough blood for your body's needs.
Research Study Groups:
This trial has the following groups:- Group 1: Polypill Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this clinical research?
"Affirmative. Per the information on clinicaltrials.gov, this research is currently recruiting participants. The trial was first uploaded to the website on November 15th 2021 and was last updated December 16th 2021, with an aim of enlisting 175 people at a single medical site."
Answered by AI
How many individuals are testing out this research experiment?
"Indeed, clinicaltrials.gov's records show that this medical trial is currently seeking participants since its initial posting on 15/11/2021 and latest update 16/12/2021. The research team require an aggregate of 175 patients from a single site for the study to move forward."
Answered by AI
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