Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT06029712
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06029712
Study Brief:
Protocol Section:
NCT06029712