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Polypill Strategy for Heart Failure With Reduced Ejection Fraction

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ClinicalTrials.gov Identifier: NCT04633005
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : December 19, 2022
Information provided by (Responsible Party):
Ambarish Pandey, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Polypill Drug: Control Rx Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Polypill Strategy for the Evidence-Based Management of Heart Failure With Reduced Ejection Fraction in an Underserved Patient Population
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Polypill Arm
Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include metoprolol succinate (a beta-blocker), empagliflozin (an SGLT2-inhibitor), and spironolactone (a mineralocorticoid antagonist). Three dose formulations of the pill, varied in metoprolol succinate dose, will be available for up-titration of the beta-blocker dose per ACC/AHA/HFSA guidelines.
Drug: Polypill
Polypill formulation consisting of metoprolol succinate, empagliflozin, and spironolactone.

Active Comparator: Control Arm
Patients will receive GDMT as usually prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.
Drug: Control Rx
Typical prescriptions of guideline-directed therapies for heart failure with reduced ejection fraction.

Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 6 months ]
    Measured by cardiac MR

Secondary Outcome Measures :
  1. NT-ProBNP level [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Serum level

  2. Medication adherence [ Time Frame: baseline, 1 month, 3 month, 6 month ]
    Pill counts, therapeutic drug monitoring, and standardized adherence questionnaire measuring patients' adherence. Possible score range from 0 to 8, with lower scores indicating a higher adherence.

  3. Kansas City Cardiomyopathy Questionnaire Quality of Life [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    23-item Kansas City Cardiomyopathy Questionnaire measures patients' quality of life. Possible score range from 0 to 100, with higher scores indicating a better quality of life.

  4. Six-minute walk distance [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Six-minute walk test

  5. HF hospitalization rate [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    Self-reported HF hospitalizations

  6. LVEF through echocardiography [ Time Frame: 6 months ]
    assessed by echocardiogram

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633005

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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Ambarish Pandey, MD    214-645-9762    ambarish.pandey@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: Ambarish Pandey, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04633005    
Other Study ID Numbers: UTexasSouthwestern
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases