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

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 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: Control Rx
Typical prescriptions of guideline-directed therapies for heart failure with reduced ejection fraction. |
- Left ventricular ejection fraction [ Time Frame: 6 months ]Measured by cardiac MR
- NT-ProBNP level [ Time Frame: baseline, 1 month, 3 months, 6 months ]Serum level
- 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.
- 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.
- Six-minute walk distance [ Time Frame: baseline, 1 month, 3 months, 6 months ]Six-minute walk test
- HF hospitalization rate [ Time Frame: baseline, 1 month, 3 months, 6 months ]Self-reported HF hospitalizations
- 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

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
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Ambarish Pandey, MD 214-645-9762 ambarish.pandey@utsouthwestern.edu |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Failure Heart Diseases Cardiovascular Diseases |