Heart Failure with reduced Ejection Fraction (HFrEF)
Conditions
Interventions
Study sites:
The National Hospital of Sri Lanka, Colombo North Teaching Hospital, Teaching Hospital Jaffna, Colombo South Teaching Hospital, National Hospital Kandy, University Hospital General Sir Jo
Sponsors
Washington University in St' Louis
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female adults ( 18 years or older) 2. Diagnosis of heart failure with reduced ejection fraction (HFrEF) including a) clinical symptoms or clinical signs or natriuretic peptide elevation AND b) echocardiographic or other evidence of reduced left ventricular ejection fraction (EF less than or equal to 40%) 3. New York Heart Association Class II, III, or IV symptoms
Exclusion criteria
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 5 mEq/L. 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. History of type 1 diabetes mellitus. 7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using a highly 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 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite rate of cardiovascular disease mortality and recurrent heart failure (HF) hospitalizations over the study duration Cardiovascular disease mortality: death attributed to acute Myocardial infarction (AMI), worsening HF, stroke, sudden cardiac death, arrhythmia, pulmonary embolism, cardiovascular procedures or their complications, other vascular causes, or death of unknown cause unless a non-cardiovascular etiology is clearly established. HF hospitalization: any unplanned admission lasting more than or equal to 24 hours with HF as the primary cause, accompanied by objective evidence of decompensation and requiring initiation or intensification of HF-specific therapy, following a period of documented clinical stability of more than or equal to 12 hours since the prior HF event. [At months 1, 3, 6, 9, 12, through study completion, an average of 18 months. ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Cardiovascular disease mortality over study duration [At months 1, 3, 6, 9, 12, through study completion, an average of 18 months.] Rate of Heart failure hospitalizations over the study duration [ At months1, 3, 6, 9, 12, through study completion, an average of 18 months.] Rate of all-cause mortality over the study duration [ At months 1, 3, 6, 9, 12, through study completion, an average of 18 months.] Change in left ventricular ejection fraction (LVEF) from baseline to 12 months and end of study, assessed by transthoracic echocardiography [At baseline, 12 months and end of study] Change in BNP (pg/mL) from at 12 months and end of study [At baseline, 12 months and end of study] Change in overall and domain specific health-related quality of life from at 12 months and end of study, assessed by the Kansas City Cardiomyopathy Questionnaire–23 (KCCQ-23 [At baseline, 12 months and end of study] Change in physician - reported NYHA functional class at 12 months and end of study [At baseline, 12 months and end of study] Adherence: assessed by pill count and the 5-item Medication Adherence Report Scale (MARS-5) [At baseline, 1, 3, 6, 9, 12 months and end of study] Persistence: proportion of participants continuing assigned therapy, with reasons for discontinuation documented [At baseline, 1, 3, 6, 9, 12 months and end of study] Dose optimisation: proportion of participants achieving target doses (Strength 3 polypill in the intervention arm; guideline-recommended doses in the usual care arm), [At 6 and 12 months and end of study] Proportion of participants experiencing any serious adverse event (SAE), defined per ICH E6(R3) GCP guidelines. [At months 1, 3, 6, 9, 12, through study completion, an average of 18 months.] Proportion of participants with adverse events of special interest over study duration. Adverse events of special interest are defined as: ? symptomatic hypotension: systolic blood pressure 50% from baseline, or at a lower threshold per physician | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Gamini Galappatthy
Consultant Cardiologist
Outcome results
None listed