A Pilot Randomized Trial Evaluating the Feasibility and Safety of a Polypill Implementation Strategy in Patients with Heart Failure with Reduced Ejection Fraction in South Asia

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1.Adults [>=18 years old)
2.Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced ejection fraction (EF=<40%)
3.New York Heart Association Class II, III, or IV symptoms

Exclusion Criteria

1.Known contraindication to any of the HFrEF polypill components (e.g., advanced renal
disease, bradycardia, allergy, amongst others).
2.Significant renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m
3.Raised serum potassium >5 mEq/L.
4.Symptomatic hypotension or systolic BP <100 mmHg as per the average of last 2 of the measurements at visit 1.
5.Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.
6.Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.
7.Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
8.Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary physician could interfere with the conduct of the study including outcome assessment.
9.Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
10.Participant’s responsible physician believes it is not appropriate for participant to participate in the study.
11.Inability or unwillingness to provide written informed consent.
12.Involvement in the planning and/or conduct of the study.
13.Unable to complete study procedures and/or plan to move out of the study site area in the next 2 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Feasibility of recruitment and adherence to study protocols based on completion of Recruitment of up to 80 participants at a rate of 4 participants per week. [At end of participant recruitment for the study]<br>2.Feasibility of recruitment and adherence to study protocols based on completion of study related procedures (screening, randomization, study drug allocation, follow-up procedures, retention, and outpatient transition) [ Week 4]<br>3.The proportion of individuals with adherence to overall and individual components of GDMT (ACE-I or ARB or ARNi, BB, MRA, and SGLT2i use at any dose in the absence of contraindications) measured by pill count and self-report using structured questionnaire [in-house] [ Week 4]<br>

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with any serious adverse events (SAEs) according to the Good Clinical Practice (GCP) definition [Week 1, Week 4]<br>Proportion of participants with adverse events of special interest (AESIs) which are hyperkalemia, worsening renal function, and hypotension. [ Week 1, Week 4]<br>Proportion of withdrawals due to adverse events [ Week 4]<br>Mean change (from baseline) in continuous serum potassium (mEq/L), controlling for baseline value [ Baseline, Week 1, Week 4]<br>Mean change (from baseline) in continuous serum creatinine (mg/dL), controlling for baseline value [ Baseline, Week 1, Week 4]<br>Change in B-type natriuretic peptide (BNP) [Baseline, Week 4]<br>Change in physician reported New York Heart Association (NYHA) functional class [ Baseline, Week 1, Week 4]<br>Change in health-related quality of life [ Baseline, Week 4]<br>Rate of HF hospitalization [ Baseline, Week 1, Week 4]<br>Rate of cardiovascular disease mortality [ Baseline, Week 1, Week 4]<br>