The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Summary
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart failure (HF) and reduced systolic function using 11C-acetate positron emission tomography (PET) and echocardiography.
Timeline
- Start
- 2018-07-05
- Primary completion
- 2022-03-23
- Completion
- 2022-03-23
Outcome
Missed primary endpoint
registry analysis (superiority test); Sacubitril/Valsartan vs Valsartan; p = 0.7594; difference in least square means -900.0 (95% CI -6781.7 to 4981.8); ANCOVA NCT03300427 ↗
registry analysis (superiority test); Sacubitril/Valsartan vs Valsartan; p = 0.8422; difference in least square means -575.5 (95% CI -6365.5 to 5214.5); ANCOVA NCT03300427 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacubitril | Small molecule | 100 mg | Oral |
| Subject | Sacubitril | Small molecule | 200 mg | Oral |
| Comparator | Valsartan | Unknown | 80 mg | Oral |
| Comparator | Valsartan | Unknown | 160 mg | Oral |