Site Initiation Visits Conducted for Heart Failure with Reduced Ejection Fraction (HFrEF) polypill Study

RemediumOne has completed the site initiation visits for the pilot phase of our project, aimed at assessing the feasibility of the study design and procedures for introducing a Heart Failure with Reduced Ejection Fraction (HFrEF) polypill. This polypill combines Guideline-Directed Medical Therapy (GDMT) into a single pill, which includes a beta blocker (BB), angiotensin receptor blocker (ARB), mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter 2 inhibitor (SGLT2i) to streamline treatment for undertreated patients.

Trial Design

• This is a proof-of-concept, multi-center, type I hybrid, randomized pilot study.
• The study will demonstrate short-term feasibility of implementation of HFrEF polypill and preliminary efficacy and safety to generate necessary data to plan a future outcomes trial.
• Participants in the control group will receive usual care and the participants in the intervention group will receive the HFrEF polypill.
• Planned to enroll 4 participants/week to achieve a target of up to 80 participants.
• HFrEF polypill combination (If combining the medicines into one capsule isn’t possible, small sachets will be used to deliver instead):
  • HFrEF polypill 1: bisoprolol 1.25 mg + losartan 50 mg + eplerenone 25 mg + dapagliflozin 10mg
    HFrEF polypill 2: bisoprolol 5 mg + losartan 100 mg + eplerenone 25 mg + dapagliflozin 10 mg
    HFrEF polypill 3: bisoprolol 10 mg + losartan 150 + eplerenone 50 mg + dapagliflozin 10 mg

The project is conducted in collaboration with Washington University in St. Louis and The George Institute for Global Health.

Following the pilot phase, a larger, adequately powered trial will be conducted to evaluate the effects of the HFrEF polypill on key cardiovascular outcomes.

Keep in touch for more updates.