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Heart Failure Polypill for Heart Failure

Phase 2

Waitlist Available

Led By Colette DeJong, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years old

Previously diagnosed with heart failure with reduced ejection fraction (<40% by echocardiogram or cardiac MRI)

Must not have

Patients who have dementia or lack capacity

Patients who cannot provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed following study completion (approximately 1 year)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to create a "polypill" that makes 4 drugs for heart failure easier to take, potentially extending life expectancy by 6 yrs & improving quality of life. Unfortunately, adherence to complex drug regimens is a problem, esp. in underserved communities.

Who is the study for?

Adults over 18 with heart failure and reduced ejection fraction (HFrEF) are eligible for this trial. It's open to those with or without HIV, who can get their meds by mail, clinic pickup, or pharmacy partner. Excluded are non-English speakers, dementia patients, the incarcerated, anyone unable to consent, and those allergic or with conditions like severe kidney disease.

What is being tested?

The study is testing a new 'polypill' combining four drugs for HFrEF against usual care. The goal is to see if the polypill improves medication adherence in underserved communities. Around 40 adults will participate in a crossover design where they'll receive both treatments at different times.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include reactions to any of the polypill components such as allergies or issues related to heart function and kidney health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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My heart pumps less blood than normal (<40% efficiency).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have dementia or any condition that affects my ability to make decisions.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed following study completion (approximately 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed following study completion (approximately 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed following study completion (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measured adherence to GDMT by pill count

Secondary study objectives

Adherence ratio to individual components of GDMT by pill count

Adverse events

Blood pressure (mmHg)

+15 more

Other study objectives

Feasibility of adherence to study protocols

Feasibility of recruitment

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: GDMT delivered in a heart failure polypillExperimental Treatment1 Intervention

The polypill intervention will be pharmacy-level over-encapsulation of heart failure medications (beta-blocker, SGLT2 inhibitor, mineralocorticoid receptor antagonist, and ACE/ARB/ARNI) into a single capsule. For patients on twice-daily sacubitril/valsartan, one dose will be included in the polypill and the second dose will be dispensed separately. The investigators will partner with a local community pharmacy with proficiency in over-encapsulation. For patients in the polypill arm, heart failure medications will be filled as usual, but rather than dispensing each medication separately, the pharmacy technician will hand-pack all once-daily heart failure medications into a small vegan capsule.

Group II: GDMT delivered as individual tabletsActive Control1 Intervention

As described above, participants who are not already prescribed a beta blocker, SGLT2i, ACE/ARB/ARNI, and MRA will be initiated on these medications prior to randomization if no contraindications exist. Participants randomized to usual care will receive their heart failure medications as individual pills. They will have the option to receive medications by mail, clinic pick-up, or pharmacy pick-up.

0 / 4Eligibility criteria met