RECRUITING

Polypill for Prevention of Cardiomyopathy

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

This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 25, 50 or 100 mg, and finerenone 10 mg daily. The study duration is 6 months, and participants will be randomized to either polypill therapy or simultaneous prescription of the individual drugs. The primary outcome is change in peak VO2 and adherence to usual care. The investigators hypothesize that the use of a polypill is feasible and improves medication adherence and peak VO2 as compared to those receiving usual care.

Official Title

Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure

Quick Facts

Study Start:2024-03-11
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06143566

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 to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with Type 2 DM
  2. * History of chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) of 25 to 90 per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of less than 5000
  3. * With either a: High risk of HF as defined by High Watch-DM score (≥11) or Elevated natriuretic peptides or Diastolic dysfunction or left ventricular hypertrophy on echocardiography
  1. * eGFR \< 25
  2. * Congestive heart failure
  3. * Hyperkalemia \> 5.0
  4. * Contraindication to any component of polypill
  5. * Pregnancy
  6. * Creatinine \>2.0mg/dL in men and \>1.8mg/dL in women
  7. * Inability to calculate WATCH-DM score
  8. * Inability to undergo exercise testing

Contacts and Locations

Study Contact

Ambarish Pandey, MD, MSCS
CONTACT
214-645-2101
ambarish.pandey@utsouthwestern.edu

Principal Investigator

Ambarish Pandey, MD, MSCS
PRINCIPAL_INVESTIGATOR
UT Southwestern

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Ambarish Pandey, MD, MSCS, PRINCIPAL_INVESTIGATOR, UT Southwestern

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 Date2024-03-11
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-03-11
Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

  • Type 2 Diabetes
  • Diabetic Cardiomyopathy
  • Hypertension
  • Polypill

Additional Relevant MeSH Terms

  • Type 2 Diabetes
  • High Blood Pressure