Table 3.
Ongoing randomized controlled trials of sacubitril/valsartan
| Study name | NCT | Patients | Estimated enrollment | Comparator | Primary endpoint | FU duration | Study start date | Estimated study completion date |
|---|---|---|---|---|---|---|---|---|
| HFN-LIFE | NCT02816736 | Advanced HFrEF patients with LVEF ≤ 35% and NYHA class IV symptom | 400 | Valsartan | Change in NT-proBNP | 24 wk | 2017-05 | 2020-09 |
| PARADISE-MI | NCT02924727 | Patients with LVEF ≤ 40% and/or pulmonary congestion after AMI | 5,650 | Ramipril | Composite endpoint of CV death, HF hospitalization, or outpatient HF | 43 mon | 2002-01 | 2021-05 |
| PARAGLIDE-HF | NCT03988634 | Patients with LVEF > 40% recently hospitalized due to acute decompensation | 800 | Valsartan | Proportional change in NT-proBNP from baseline to the average of weeks 4 and 8 | 8 wk | 2019-06 | 2021-09 |
| PERSPECTIVE | NCT02884206 | Patients with chronic HF (LVEF > 40%) | 593a | Valsartan | Change from baseline in the CogState Global Cognitive Composite Score (GCCS) | 3 yr | 2016-11 | 2022-03 |
NCT, National Clinical Trial; FU, follow-up; HFN-LIFE, EntrestoTM (LCZ696) in Advanced Heart Failure (LIFE Study); HFrEF, heart failure with reduced ejection fraction; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; NT-proBNP, N-terminal-pro B-type NP; PARADISE-MI, Prospective ARNI vs. ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI; AMI, acute myocardial infarction; CV, cardiovascular; HF, heart failure; PARAGLIDE-HF, Changes in NT-proBNP and Outcomes, Safety, and Tolerability in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization and Initiated In-hospital or Within 30 Days Post-discharge; PERSPECTIVE, Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction.
Actual enrollment.