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

Controlled Trial on the Short-term Effects of Sacubitril/Valsartan Therapy on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Patients With NYHA II-III Heart Failure and Reduced Systolic Function Using 11C-acetate Positron Emission Tomography and Echocardiography

ClinicalTrials.gov Identifier: NCT03300427

Novartis Reference Number: CLCZ696BFI03

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The study will assess the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on cardiac oxygen consumption and 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.

Condition 
Heart Failure
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
60 participants
Start date 
Jul 05, 2018
Completion date 
Feb 28, 2021
Gender 
All
Age(s)
40 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
sacubitril/valsatran
sacubitril/valsatran 100 or 200 mg BID
Drug
valsartan
Valsartan 80 or 160 mg BID
Drug
placebo to valsartan
placebo to valsartan 80 or 160 BID
Drug
placebo to sacubitril/valsartan
placebo to sacubitril/valsartan 100 or 200 mg BID

Eligibility Criteria

Inclusion criteria:

40-75 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

Study Locations

Finland
Novartis Investigative Site
Recruiting
Turku,
-
Finland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]