CompletedPhase 4

The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients

Finland55 participantsStarted 2018-07-05

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) \< 45 ml/min * Serum potassium \> 5.2 mmol/l and creatinine \>1.5 x ULN

What they're measuring

Myocardial Energetic Efficiency

Timeframe: Baseline, Visit 3 (approximately Week 8)

Change From Baseline in Myocardial Energetic Efficiency

Timeframe: Baseline, Visit 3 (approximately Week 8)

Viable Myocardial Energetic Efficiency (Sensitivity Analysis)

Timeframe: Baseline, Visit 3 (approximately Week 8)

Change From Baseline in Viable Myocardial Energetic Efficiency (Sensitivity Analysis)

Timeframe: Baseline, Visit 3 (approximately Week 8)

Trial details

NCT IDNCT03300427

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-23

Results submitted2023-03-20

View on ClinicalTrials.gov More Heart Failure trials