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Polypill for Cardiomyopathy Prevention in Type 2 Diabetes (PolyPreventHF Trial)

Phase 1 & 2
Recruiting
Led By Ambarish Pandey, MD, MSCS
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Type 2 DM and urinary albumin-to-creatinine ratio of 30 to less than 300 and an estimated glomerular filtration rate (eGFR) of 25 to 90 ml per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) 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
Be older than 18 years old
Must not have
Congestive heart failure
Contraindication to any component of polypill
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 month, and 6 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a polypill with 3 meds can help people with type 2 diabetes and a high risk of heart failure. It will measure if it improves med adherence and physical performance, compared to usual care.

Who is the study for?
This trial is for people with type 2 diabetes who are at high risk of heart failure. They should have a certain level of kidney function and protein in their urine, but not be on dialysis or have severe kidney disease. Pregnant individuals, those unable to exercise for tests, or with very high potassium levels can't join.
What is being tested?
The study is testing a polypill combining three medications (empagliflozin, losartan, finerenone) against usual care over three months. It aims to see if the pill helps patients stick to their treatment better and improves oxygen use during peak exercise.
What are the potential side effects?
Possible side effects may include low blood pressure from losartan, dehydration or urinary tract infections from empagliflozin, and increased potassium levels which could affect the heart rhythm due to finerenone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Type 2 diabetes, moderate kidney issues, and a high risk of heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with congestive heart failure.
Select...
I am allergic or react badly to one of the ingredients in the polypill.
Select...
My kidney function is very low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 month, and 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 month, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxygen uptake during peak exercise (Peak VO2)
Secondary study objectives
Urine albumin to creatinine ratio
Other study objectives
Medication Adherence

Side effects data

From 2008 Phase 2 trial • 475 Patients • NCT00603590
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polypill
Control

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PolypillExperimental Treatment1 Intervention
Participants will take a polypill containing finerenone 10 mg, empagliflozin 12.5 mg, and losartan (50 mg or 100 mg) daily.
Group II: Usual CareActive Control1 Intervention
Participants will continue to take normal medications for diabetes and high blood pressure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polypill
2011
Completed Phase 3
~2880

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,088 Previous Clinical Trials
1,059,660 Total Patients Enrolled
Ambarish Pandey, MD, MSCSPrincipal InvestigatorUT Southwestern
2 Previous Clinical Trials
190 Total Patients Enrolled
~28 spots leftby Sep 2025
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