COMPLETED

Polypill Strategy for Heart Failure With Reduced Ejection Fraction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Polypill Strategy for the Evidence-Based Management of Heart Failure With Reduced Ejection Fraction in an Underserved Patient Population

Quick Facts

Study Start:2021-11-15
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04633005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults age \> = 18 years
  2. * HF with left ventricular ejection fraction \<= 40% within 3 months of screening who are not on target dose guideline directed medical therapy
  3. * New York Heart Association class II, III, or IV symptoms
  1. * Age \< 18
  2. * Systolic blood pressure \< 110 mm Hg at enrollment if not on HTN therapy.
  3. * Systolic blood pressure \<100 mm Hg at enrollment if on HTN therapy
  4. * Serum creatinine \>2.5 for men and 2.0 for women
  5. * Serum potassium \> 5.0 mEq/L
  6. * Current need for inotropes
  7. * Cardiac index \< 2.2 L/min/m2
  8. * History of revascularization within 30 days or plan for revascularization
  9. * History of type 1 diabetes mellitus
  10. * History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i)
  11. * Contraindication to receive any of the components of the polypill
  12. * Pregnancy
  13. * \< 6 month expected survival
  14. * Inability to provide written informed consent
  15. * Persistent or permanent atrial fibrillation who may not have optimal MRI imaging
  16. * Extreme obesity (BMI \> 45 kg/m2)
  17. * ICD/Pacemaker devices that are incompatible with MRI

Contacts and Locations

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75209
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-15
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2021-11-15
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • heart failure
  • adherence
  • LVEF
  • GDMT

Additional Relevant MeSH Terms

  • Heart Failure