Status:
COMPLETED
Effects of Sacubitril/Valsartan on Exercise Capacity, Natriuretic Peptides and Ventricular Remodeling in Heart Failure
Lead Sponsor:
Centro Cardiologico Monzino
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Brief Summary
Background: Sacubitril/valsartan, a novel therapy in the treatment of heart failure with reduced ejection fraction (HFrEF), has recently proved efficacy in improving exercise tolerance and cardiac per...
Detailed Description
Given the recent introduction of the drug into the clinical routine, the evaluation of the experience "on the field" is important to refine the clinical management of patients treated with sacubitril ...
Eligibility Criteria
Inclusion
- New York Heart Association Class (NYHA) II-III
- stable clinical conditions
- reduced ejection fraction (\< 35%)
- capability to perform a cardiopulmonary exercise test (CPET)
Exclusion
- moderate-severe chronic obstructive pulmonary disease
- chronic oxygen therapy
- contraindication to CPET
- planned procedures (i.e. cardiac surgery, revascularization procedures, CRT implantation) that could per se impact on CPET, echocardiography and laboratory values
Key Trial Info
Start Date :
October 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04434170
Start Date
October 15 2018
End Date
December 15 2021
Last Update
February 7 2024
Active Locations (1)
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1
Centro Cardiologico Monzino
Milan, Italy, 20138