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NCT04633005 · ClinicalTrials.gov registry record · Phase 2

Polypill Strategy for Heart Failure With Reduced Ejection Fraction

A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
Phase 2
Development phase
212
Enrollment target

NCT04633005 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 212 participants.

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The verdict

NCT04633005, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
212 participants
Enrollment target

Study 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.

Interventions

  • DRUG Polypill
  • DRUG Control Rx

Trial Details

FieldValue
Enrollment Target 212 participants
Start Date 2021-11-15
Est. Completion 2025-10-31
Phase Phase 2

What the Registry Record Tells You About NCT04633005

The ClinicalTrials.gov registry entry for NCT04633005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Polypill is the first listed.

NCT04633005 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04633005 about?

NCT04633005 is a clinical study titled "Polypill Strategy for Heart Failure With Reduced Ejection Fraction". 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...

What is the current status of trial NCT04633005?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2021-11-15. Estimated completion is 2025-10-31.

What interventions are being tested in trial NCT04633005?

The interventions under investigation include: Polypill (DRUG), Control Rx (DRUG).

Who is sponsoring clinical trial NCT04633005?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.