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Heart Failure Polypill for Heart Failure

Q: To what degree could a polypill containing GDMT endanger individuals with heart failure?

<p>While preliminary data exists to validate the safety of GDMT given in a <a href="https://www.withpower.com/clinical-trials/heart-failure">heart failure</a> polypill, there is no evidence yet confirming its efficacy. This has led our team at Power to assign it an interim rating of 2 on their 1-3 scale.</p>

Q: Has the recruitment period for this clinical experiment concluded?

<p>Per the information found on clinicaltrials.gov, this trial is no longer taking candidates since its initial posting date of November 1st 2023 and last updated date of September 1st 2023. However, there are still 1212 other trials that require enrolment as of now.</p>

Phase 2

Recruiting

Led By Priscilla Hsue, 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 2, 4, 6, and 8 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 2, 4, 6, and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 2, 4, 6, and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 2, 4, 6, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measured adherence to GDMT by pill count

Secondary outcome measures

Adherence ratio to individual components of GDMT by pill count

Adverse events

Blood pressure (mmHg)

+9 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,515 Total Patients Enrolled

UCSF CAPS-HIV Innovative GrantUNKNOWN

UCSF CFAR-ARI HIV Boost AwardUNKNOWN

Frequently Asked Questions

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

To what degree could a polypill containing GDMT endanger individuals with heart failure?

"While preliminary data exists to validate the safety of GDMT given in a heart failure polypill, there is no evidence yet confirming its efficacy. This has led our team at Power to assign it an interim rating of 2 on their 1-3 scale."

Answered by AI

Has the recruitment period for this clinical experiment concluded?

"Per the information found on clinicaltrials.gov, this trial is no longer taking candidates since its initial posting date of November 1st 2023 and last updated date of September 1st 2023. However, there are still 1212 other trials that require enrolment as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heart Failure Polypill at a Safety Net Hospital

2024. "Heart Failure Polypill at a Safety Net Hospital". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029712.