Polypill for Prevention of Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
eGFR < 25
Congestive heart failure
Hyperkalemia > 5.0
Contraindication to any component of polypill
Trial design
Design model
Single group
Treatments tested in this trial
Polypill
DrugA combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.
Combined prescription of the individual medications
DrugWe will initiate participants on an ARB, SGLT2i, and Finerenone if they are not in the polypill arm.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: PolypillExperimental treatment 1 intervention
Group B: Combined prescription of the individual medicationsActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 3-month, and 6-monthSecondary outcomes
1
Urine albumin to creatinine ratio
The ratio of urinary albumin to creatinine will be measured.
Time frame
Baseline, 3 month, and 6 monthOther outcomes
1
Medication Adherence
Assessed via the Morisky Medication Adherence Score - 8. The score ranges from 0 to 8, with 8 meaning highest adherence.
Time frame
Baseline, 1 month, 3 month, and 6 monthSponsors and contacts
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Source ClinicalTrials.gov