NCT04633005CompletedPhase 2
Polypill Strategy for Heart Failure With Reduced Ejection Fraction
Polypill Strategy for the Evidence-Based Management of Heart Failure With Reduced Ejection Fraction in an Underserved Patient Population
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
Heart failure with a reduced ejection fraction (HFrEF) represents a significant public health burden in the United States, with a growing prevalence particularly among African Americans and Hispanic Americans and individuals of low socioeconomic status (SES). Although effective therapies exist, gaps in their uptake contribute substantially to the excess burden of heart failure. The "polypill" is an inexpensive once daily pill containing three agents proven to improve morbidity and mortality in heart failure and represents potential strategy for increasing the utilization of proven HF therapies. The proposed study is a pragmatic, single-center, randomized trial to test the feasibility and effectiveness of a polypill-based strategy for the treatment of HFrEF in a low-income, racially diverse population.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 212 (actual)
- First submitted
- 2 Nov 2020
- Start date
- 15 Nov 2021
- Primary completion date
- 15 Oct 2025
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure
- NCT number
- NCT04633005
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 212
- From 15 Nov 2021 to the primary completion date, 15 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systolic blood pressure \< 110 mm Hg at enrollment if not on HTN therapy.
- Systolic blood pressure \<100 mm Hg at enrollment if on HTN therapy
Other illness
- Cardiac index \< 2.2 L/min/m2
- History of revascularization within 30 days or plan for revascularization
- History of type 1 diabetes mellitus
Lab values
- Serum creatinine \>2.5 for men and 2.0 for women
- Serum potassium \> 5.0 mEq/L
- History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i)
Age
- Age \< 18
Other
- Current need for inotropes
- Contraindication to receive any of the components of the polypill
- Pregnancy
- \< 6 month expected survival
- Inability to provide written informed consent
- Persistent or permanent atrial fibrillation who may not have optimal MRI imaging
- Extreme obesity (BMI \> 45 kg/m2)
- ICD/Pacemaker devices that are incompatible with MRI
Who the study is looking for
- Adults age \> = 18 years
- HF with left ventricular ejection fraction \<= 40% within 3 months of screening who are not on target dose guideline directed medical therapy
- New York Heart Association class II, III, or IV symptoms
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.