Polypill for Prevention of Cardiomyopathy
PolyPreventHF
Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes
Started Mar 2024
Longer than P75 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedStudy Start
First participant enrolled
March 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 17, 2025
June 1, 2025
3.5 years
November 16, 2023
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxygen uptake during peak exercise (Peak VO2)
The ability of a polypill to improve or prevent declines in exercise capacity as measured by changes in peak oxygen uptake at exercise will be assessed.
Baseline, 3-month, and 6-month
Secondary Outcomes (1)
Urine albumin to creatinine ratio
Baseline, 3 month, and 6 month
Other Outcomes (1)
Medication Adherence
Baseline, 1 month, 3 month, and 6 month
Study Arms (2)
Polypill
EXPERIMENTALParticipants will take a polypill containing finerenone 10 mg, empagliflozin 12.5 mg, and losartan (25, 50 mg, or 100 mg) daily.
Combined prescription of the individual medications
ACTIVE COMPARATORParticipants will be initiated on an SGLT2i, ARB, or finerenone if they are not already on the medication class.
Interventions
A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.
We will initiate participants on an ARB, SGLT2i, and Finerenone if they are not in the polypill arm.
Eligibility Criteria
You may qualify if:
- Patients with Type 2 DM
- 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
- 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
You may not qualify if:
- eGFR \< 25
- Congestive heart failure
- Hyperkalemia \> 5.0
- Contraindication to any component of polypill
- Pregnancy
- Creatinine \>2.0mg/dL in men and \>1.8mg/dL in women
- Inability to calculate WATCH-DM score
- Inability to undergo exercise testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
Related Publications (4)
Lee MMY, McMurray JJV, Lorenzo-Almoros A, Kristensen SL, Sattar N, Jhund PS, Petrie MC. Diabetic cardiomyopathy. Heart. 2019 Feb;105(4):337-345. doi: 10.1136/heartjnl-2016-310342. Epub 2018 Oct 18. No abstract available.
PMID: 30337334BACKGROUNDSegar MW, Vaduganathan M, Patel KV, McGuire DK, Butler J, Fonarow GC, Basit M, Kannan V, Grodin JL, Everett B, Willett D, Berry J, Pandey A. Machine Learning to Predict the Risk of Incident Heart Failure Hospitalization Among Patients With Diabetes: The WATCH-DM Risk Score. Diabetes Care. 2019 Dec;42(12):2298-2306. doi: 10.2337/dc19-0587. Epub 2019 Sep 13.
PMID: 31519694BACKGROUNDFilippatos G, Anker SD, Agarwal R, Ruilope LM, Rossing P, Bakris GL, Tasto C, Joseph A, Kolkhof P, Lage A, Pitt B; FIGARO-DKD Investigators. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial. Circulation. 2022 Feb 8;145(6):437-447. doi: 10.1161/CIRCULATIONAHA.121.057983. Epub 2021 Nov 13.
PMID: 34775784BACKGROUNDZinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PMID: 26378978BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ambarish Pandey, MD, MSCS
UT Southwestern
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 16, 2023
First Posted
November 22, 2023
Study Start
March 11, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share