Date

2025-01-23

Protocol

Protocol changed

Item Changed

Secondary outcome

Previous Version

1.Proportion of participants with any serious adverse events (SAEs) according to the Good Clinical Practice (GCP) definition [Week 1, Week 4 ]; 2.Proportion of participants with adverse events of special interest (AESIs) which are hyperkalemia, worsening renal function, and hypotension. [Week 1, Week 4 ]; 3.Proportion of withdrawals due to adverse events [Week 4 ]; 4.Mean change (from baseline) in continuous serum potassium (mEq/L), controlling for baseline value [Baseline, Week 1, Week 4 ]; 5.Mean change (from baseline) in continuous serum creatinine (mg/dL), controlling for baseline value [Baseline, Week 1, Week 4 ]; 6.Change in B-type natriuretic peptide (BNP) [Baseline, Week 4 ]; 7.Change in physician reported New York Heart Association (NYHA) functional class [Baseline, Week 1, Week 4 ]; 8.Change in health-related quality of life [Baseline, Week 4 ]; 9.Rate of HF hospitalization [Baseline, Week 1, Week 4 ]; 10.Rate of cardiovascular disease mortality [Baseline, Week 1, Week 4 ]

Next Version

1. Proportion of participants with any serious adverse events (SAEs) according to the Good Clinical Practice (GCP) definition [Time Frame: Week 1, Week 4]; 2. Proportion of participants with adverse events of special interest (AESIs) which are hyperkalemia, worsening renal function, and hypotension. [Time Frame: Week 1, Week 4]; 3. Proportion of withdrawals due to adverse events [Time Frame: Week 4]; 4. Mean change (from baseline) in continuous serum potassium (mEq/L), controlling for baseline value [Time Frame: Baseline, Week 1, Week 4]; 5. Mean change (from baseline) in continuous serum creatinine (mg/dL), controlling for baseline value [Time Frame: Baseline, Week 1, Week 4]; 6. Change in B-type natriuretic peptide (BNP) [Time Frame: Baseline, Week 4]; 7. Change in physician reported New York Heart Association (NYHA) functional class [Time Frame: Baseline, Week 1, Week 4]; 8. Change in health-related quality of life [Time Frame: Baseline, Week 4]; 9. Rate of HF hospitalization [Time Frame: Baseline, Week 1, Week 4]; 10. Rate of cardiovascular disease mortality [Time Frame: Baseline, Week 1, Week 4]; 11. Acceptability, feasibility, and appropriateness assessed by key informant in-depth interviews with select patients and healthcare providers [Time Frame: Week 4]; 12. Cost-effectiveness assessed by a patient cost diary [Time Frame: Week 1, Week 4];