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Effects of Sacubitril/Valsartan on Exercise Capacity, Natriuretic Peptides and Ventricular Remodeling in Heart Failure

NCT04434170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2024-02-07

No results posted yet for this study

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 performance. Cardiopulmonary exercise test (CPET) provides functional prognostic parameters for patient with HFrEF (i.e. peakVO2 and ventilation/CO2 production \[VE/VCO2\] slope) and it is a well-recognized, valuable, accurate tool for risk stratification.

Aim of the study and methods: The aim of the study is to prospectively enroll a cohort of 100 HFrEF outpatients eligible for sacubitril/valsartan and perform serial CPET, laboratory and echocardiographic assessments before and during the gradual titration of the treatment, in order to evaluate its effects on cardiopulmonary function and left ventricular remodeling. The procedures will be repeated along the follow-up at 1, 2 and 3 months after the enrollment (titration period) and at 6 months after the reach of the maximum tolerated dose.

Conditions

Interventions

DRUG

Sacubitril-Valsartan

outpatients who start treatment with sacubitril/valsartan according to guidelines will andergo cardiopulmonary exercise testing evaluation

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Piergiuseppe Agostoni, MD · Centro Cardiologico Monzino

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-11-30
Completion
2021-12-15
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434170 on ClinicalTrials.gov