Phase 4
Completed N=55
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Source: ClinicalTrials.gov NCT03300427 ↗Enrolled (actual)
55
Serious AEs
1.8%
Results posted
Jan 2024
Primary outcomePrimary: Myocardial Energetic Efficiency — 48621.3; 50035.7; 50301.0; 52942.8 (((mmhg x ml x bpm) /g)/(1/min))
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Energetic Efficiency |
48621.3; 50035.7; 50301.0; 52942.8 | — |
| PRIMARY Change From Baseline in Myocardial Energetic Efficiency |
1679.8; 2907.1 | 0.7594 |
| PRIMARY Viable Myocardial Energetic Efficiency (Sensitivity Analysis) |
48163.0; 49575.6; 49914.4; 52249.9 | — |
| PRIMARY Change From Baseline in Viable Myocardial Energetic Efficiency (Sensitivity Analysis) |
1751.4; 2674.3 | 0.8422 |
Eligibility Criteria
Inclusion criteria
- 40-80 years of age
- Chronic HF with reduced EF (left ventricle EF 25-35%) and NYHA class II-III symptoms.
- Systolic BP 110-160 mm Hg
- Optimal standard HF therapy according to European Society of Cardiology (ESC) guidelines at a stable dose for at least 4 weeks before the screening visit.
Exclusion criteria
- Estimated glomerular filtration rate (eGFR) 5.2 mmol/l and creatinine >1.5 x ULN
Data sourced from ClinicalTrials.gov (NCT03300427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.