What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for heart failure, such as beta blockers, ACE inhibitors or ARBs, and mineralocorticoid receptor antagonists, have well-documented side effects. Beta blockers can cause fatigue, bradycardia, and hypotension. ACE inhibitors and ARBs may lead to cough, hyperkalemia, and renal dysfunction. Mineralocorticoid receptor antagonists, like spironolactone and eplerenone, can cause hyperkalemia, renal impairment, and gynecomastia. These side effects are important considerations in the management of heart failure.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure that align with the polypill strategy. These include beta-blockers like carvedilol and metoprolol succinate, which reduce mortality and improve heart function. ACE inhibitors such as enalapril and ARBs like valsartan are also approved for reducing morbidity and mortality in heart failure patients. Additionally, mineralocorticoid receptor antagonists like spironolactone and eplerenone have been shown to provide significant benefits in heart failure management. These medications, often used in combination, form the cornerstone of heart failure treatment by improving survival rates and reducing hospitalizations.

What other types of research exist?

Promising novel alternatives to the Polypill for heart failure patients include: 1) SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) which have shown significant benefits in heart failure with reduced ejection fraction (HFrEF); 2) Vericiguat, a soluble guanylate cyclase stimulator, which has demonstrated efficacy in reducing heart failure-related hospitalizations and cardiovascular death; 3) Omecamtiv mecarbil, a cardiac myosin activator, which has shown potential in improving cardiac function and outcomes in HFrEF patients. These therapies represent significant advancements and may offer effective alternatives to the Polypill strategy.

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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 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

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

Cough

100%

80%

60%

40%

20%

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

0 / 12Eligibility criteria met

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.