Using a polypill to treat 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
This study is testing whether a combination pill can help people with heart failure feel better and stick to their treatment more easily.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04633005 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and effectiveness of a polypill strategy for treating heart failure with reduced ejection fraction (HFrEF) in a low-income, racially diverse population. The polypill combines multiple medications that have been proven to improve outcomes in heart failure, potentially increasing adherence and reducing the pill burden for patients. The trial will be conducted as a pragmatic, single-center, randomized trial at the University of Texas Southwestern Medical Center, targeting adults who are not currently receiving optimal guideline-directed medical therapy for HFrEF.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with HFrEF and New York Heart Association class II, III, or IV symptoms who are not on optimal therapy.
Not a fit: Patients with contraindications to the medications in the polypill or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve medication adherence and health outcomes for patients with heart failure.
How similar studies have performed: Other studies have shown promise in using combination therapies for heart failure, but this specific polypill approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults age \> = 18 years * HF with left ventricular ejection fraction \<= 40% within 3 months of screening who are not on optimal guideline directed medical therapy * New York Heart Association class II, III, or IV symptoms Exclusion Criteria: * Age \< 18 * 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 * Serum creatinine \>2.5 for men and 2.0 for women * Serum potassium \> 5.0 mEq/L * Current need for inotropes * Cardiac index \< 2.2 L/min/m2 * History of revascularization within 30 days or plan for revascularization * History of type 1 diabetes mellitus * History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i) * Contraindication to receive any of the components of the polypill * Pregnancy * \< 12 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.