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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, and 3 month.
Awards & highlights
PolyPreventHF Trial 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.Check my eligibility
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.See study design
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.
PolyPreventHF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Type 2 diabetes, moderate kidney issues, and a high risk of heart failure.
PolyPreventHF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, and 3 month.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, and 3 month.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen uptake during peak exercise (Peak VO2)
Secondary outcome measures
Urine albumin to creatinine ratio
Other outcome measures
Medication Adherence
Side effects data
From 2008 Phase 2 trial • 475 Patients • NCT006035901%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polypill
Control
PolyPreventHF 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
1,048 Previous Clinical Trials
1,053,675 Total Patients Enrolled
Ambarish Pandey, MD, MSCSPrincipal InvestigatorUT Southwestern
2 Previous Clinical Trials
150 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What credentials must a participant possess to join this investigation?
"In order to meet the criteria for this clinical trial, individuals must have type 2 diabetes and be between 18-100 years old. Sixty participants are being sought out in total."
Answered by AI
Is enrollment for this research endeavor still accessible to participants?
"According to the clinicaltrials.gov page, this experiment is no longer enrolling participants; it was posted on December 29th of 2023 and last modified November 16th of the same year. However, a plethora of other trials are still actively acquiring subjects for their research."
Answered by AI
Does this experimental protocol include access for older individuals?
"To be eligible for the trial, applicants must between 18 and 100 years old. The database reveals 117 studies catering to minors while 1591 provide care for those over 65."
Answered by AI
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