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NCT06029712 · ClinicalTrials.gov registry record · Phase 2
Heart Failure Polypill at a Safety Net Hospital
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT06029712 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 35 participants.
The verdict
NCT06029712, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
A novel four-drug regimen for heart failure with reduced ejection fraction (HFrEF) extends patients' life expectancy by an average of 6 years compared to traditional therapies, in addition to improving quality of life. Unfortunately, uptake of this complex multi-drug regimen has been low, especially among underserved communities with barriers to medication adherence. Although combination tablets have transformed access to care for conditions such as HIV and tuberculosis, no combination pill is available for HFrEF. In the proposed study, the investigators will utilize inexpensive over-encapsulation techniques to develop a novel combination pill ("polypill") for patients with HFrEF. In Aim 1, the investigators will conduct stakeholder interviews with patients, providers, and pharmacists to inform the design of a HFrEF polypill. In Aim 2, the investigators will conduct a pilot, single-center, crossover randomized clinical trial to investigate whether, compared to usual care, a HFrEF polypill increases medication adherence among 20-40 adults with HFrEF. Given the high daily pill burden among patients with HIV and HFrEF, the investigators aim to recruit a subgroup of patients with HIV (\~10-20 participants) in addition to a subgroup of patients without HIV (\~10-20 participants).
Interventions
- DRUG Control Rx
- DRUG Heart failure polypill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2025-01-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06029712
The ClinicalTrials.gov registry entry for NCT06029712 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control Rx is the first listed.
NCT06029712 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06029712 about?
NCT06029712 is a clinical study titled "Heart Failure Polypill at a Safety Net Hospital". A novel four-drug regimen for heart failure with reduced ejection fraction (HFrEF) extends patients' life expectancy by an average of 6 years compared to traditional therapies, in addition to improving quality of life. Unfortunately, uptake of this complex multi-drug regimen has been low, especially...
What is the current status of trial NCT06029712?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2024-02-27. Estimated completion is 2025-01-29.
What interventions are being tested in trial NCT06029712?
The interventions under investigation include: Control Rx (DRUG), Heart failure polypill (DRUG).
Who is sponsoring clinical trial NCT06029712?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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