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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
Must not have
Systolic blood pressure < 110 mm Hg at enrollment if not on HTN therapy
Serum creatinine > 2.5 for men and 2.0 for women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 month, 6 month
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a single pill for low-income, racially diverse patients with heart failure. The pill combines several effective medications, making it easier for patients to take their treatment regularly. The goal is to improve heart function and reduce symptoms by simplifying the treatment process.

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.
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.
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 below
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I have moderate to severe heart condition symptoms.
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My heart's pumping ability is reduced and I'm not on the best treatment plan yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is below 110 mm Hg and I'm not on blood pressure medication.
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My kidney function test shows creatinine above 2.5 (men) or 2.0 (women).
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I have type 1 diabetes.
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I cannot take certain medications due to adverse reactions.
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I am allergic to or cannot take certain heart or diabetes medications.
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My BMI is over 45.
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I currently need medication to help my heart pump more effectively.
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I have had or am planning to have a procedure to improve blood flow within the last 30 days.
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I am under 18 years old.
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My blood pressure is below 100 mm Hg while on medication for hypertension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 month, 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 month, 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Left ventricular ejection fraction
Secondary study objectives
HF hospitalization rate
Kansas City Cardiomyopathy Questionnaire Quality of Life
LVEF through echocardiography
+3 more

Side effects data

From 2008 Phase 2 trial • 475 Patients • NCT00603590
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polypill
Control

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The polypill strategy for treating Heart Failure with Reduced Ejection Fraction (HFrEF) typically includes beta-blockers, ACE inhibitors (or ARBs), and mineralocorticoid receptor antagonists. Beta-blockers work by reducing the heart rate and decreasing the force of contraction, which lowers the heart's oxygen demand and helps prevent further damage to the heart muscle. ACE inhibitors (or ARBs) help relax blood vessels and reduce blood pressure, making it easier for the heart to pump blood. Mineralocorticoid receptor antagonists reduce fluid retention and decrease the workload on the heart. Together, these medications improve heart function, reduce symptoms, and decrease the risk of hospitalization and death, making them crucial for managing heart failure.

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
1,087 Previous Clinical Trials
1,058,877 Total Patients Enrolled
26 Trials studying Heart Failure
13,577 Patients Enrolled for Heart Failure

Media Library

Polypill (Cardiovascular Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04633005 — Phase < 1
Heart Failure Research Study Groups: Polypill Arm, Control Arm
Heart Failure Clinical Trial 2023: Polypill Highlights & Side Effects. Trial Name: NCT04633005 — Phase < 1
Polypill (Cardiovascular Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04633005 — Phase < 1
~24 spots leftby Jun 2025