Date

2025-01-23

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).; Significant renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m Raised serum potassium >5 mEq/L.; Symptomatic hypotension or systolic BP <100 mmHg as per the average of last 2 of the measurements at visit 1.; Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.; Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.; 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).; 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.; 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.; Participant’s responsible physician believes it is not appropriate for participant to participate in the study.; Inability or unwillingness to provide written informed consent.; Involvement in the planning and/or conduct of the study.; Unable to complete study procedures and/or plan to move out of the study site area in the next 2 months.

Next Version

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 m2 or creatinine clearance 30 mL/min) ; 3. Raised serum potassium >5 mEq/L. ; 4. Symptomatic hypotension or systolic BP <100 mmHg as per the average of last 2 of the 3 measurements at visit 1. ; 5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1. ; 6. Cardiogenic shock and/or current use of inotropes ; 7. Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment. ; 8. 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). ; 9. 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. ; 10. 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. ; 11. Participant’s responsible physician believes it is not appropriate for participant to participate in the study. ; 12. Inability or unwillingness to provide written informed consent.; 13. Involvement in the planning and/or conduct of the study. ; 14. Unable to complete study procedures and/or plan to move out of the study site area in the next 2 months.