Status:
COMPLETED
Heart Failure Polypill at a Safety Net Hospital
Lead Sponsor:
University of California, San Francisco
Conditions:
Heart Failure With Reduced Ejection Fraction
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 improvin...
Detailed Description
Hypothesis: Compared with usual care, a HFrEF polypill implementation strategy will increase adherence to GDMT 4 weeks and reduce total daily pill burden among patients with HFrEF. Rationale:HFrEF am...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06029712
Start Date
February 27 2024
End Date
January 29 2025
Last Update
December 31 2025
Active Locations (1)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110