Could a single pill transform heart failure care for underserved patients?
NCT ID NCT06029712
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a 'polypill' that combines four heart failure medications into one capsule, aiming to make it easier for patients to stick with their treatment. The trial included 35 adults with heart failure and reduced ejection fraction, some of whom also had HIV. Researchers measured adherence by pill count and questionnaires to see if the polypill improved medication-taking compared to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Heart failure polypill (combination of beta blocker, SGLT2i, MRA, and ACE/ARB/ARNI)
- What this could lead to
- If successful, this polypill could make it easier for people with heart failure to take their life-saving medications, potentially improving adherence and health outcomes.
- What could go wrong
- This is a small pilot study with only 35 participants, so results may not apply to everyone. The polypill is hand-packed, which may not be scalable or practical for widespread use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Adults age 18+ with heart failure (current or prior NYHA stage II-IV) * Ejection fraction \<50% on the most recent echocardiogram or MRI * Last eGFR \> 30 * Able to conveniently obtain medications through one of 3 available mechanisms (mail, pick up at a ZSFG clinic, or pick up at Daniel's pharmacy) * Working phone number for telephone visits * In addition to the inclusion criteria above, the investigators will preferentially recruit the following patient groups: people with HIV for a recruitment subgroup; patients who are less connected to cardiology care; people who are on \<4 pillars of GDMT, and have difficulty with medication adherence (as evidenced by detectable HIV viral load or refill gaps in Epic); and people who do not use bubble packs and do not have daily medication support staff for med administration. Exclusion criteria: * Patients who are not fluent in English (due to constraints of the small pilot trial) * Patients who are incarcerated * Patients who cannot provide informed consent * Patients with a ventricular assist device (VAD) or patients with an MI, unstable angina, stroke, or TIA within 12 weeks prior to enrollment * Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods). * Concomitant medical condition which in the opinion of the study team could interfere with the safe conduct of the study including outcome assessment. * Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible. * Participant's responsible physician believes it is not appropriate for participant to take part in the study. * Unable to complete study procedures and/or plan to move out of the study area in the next 2 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
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