Status:
COMPLETED
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief 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 valsa...
Detailed Description
Subjects were randomized into valsartan or sacubitril/valsartan arms in a 1:1 ratio. Regardless of the treatment arm a subject is in, the study drug was up-titrated to the highest tolerated dose level...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03300427
Start Date
July 5 2018
End Date
March 23 2022
Last Update
January 5 2024
Active Locations (1)
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1
Novartis Investigative Site
Turku, Finland, 20521