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

NCT04434170 | Completed FDA Drug

• 1 other identifier: Entresto CPET
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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 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

Heart Failure

Keywords

sacubitril/valsartan; exercise; cardiopulmonary exercise test; left ventricular remodeling

Outcome Measures

Primary Outcomes (4)

• VO2 evaluation after treatment

  changes in peak VO2 at cardiopulmonary exercise test

  1 month after start of treatment with sacubitril/valsartan

• VO2 evaluation after treatment

  changes in peak VO2 at cardiopulmonary exercise test

  2 months after start of treatment with sacubitril/valsartan

• VO2 evaluation after treatment

  changes in peak VO2 at cardiopulmonary exercise test

  3 months after start of treatment with sacubitril/valsartan

• VO2 evaluation after treatment

  changes in peak VO2 at cardiopulmonary exercise test

  9 months after start of treatment with sacubitril/valsartan

Secondary Outcomes (14)

• lung function evaluation after treatment

  1 month after start of treatment with sacubitril/valsartan

• lung function evaluation after treatment

  2 months after start of treatment with sacubitril/valsartan

• lung function evaluation after treatment

  3 months after start of treatment with sacubitril/valsartan

• lung function evaluation after treatment

  9 months after start of treatment with sacubitril/valsartan

• DLCO

  1 month after start of treatment with sacubitril/valsartan

Study Arms (1)

Heart failure

outpatients with heart failure with reduced ejection fraction in treatment with sacubitril/valsartan according to guidelines

Drug: Sacubitril-Valsartan

Interventions

Sacubitril-Valsartan DRUG

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

Heart failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HFrEF outpatients eligible for sacubitril/valsartan according to guidelines and perform serial CPET, laboratory and echocardiographic assessments before and during the gradual titration of the treatment

You may qualify if:

• New York Heart Association Class (NYHA) II-III
• stable clinical conditions
• reduced ejection fraction (\< 35%)
• capability to perform a cardiopulmonary exercise test (CPET)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity; Ventricular Remodeling

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Piergiuseppe Agostoni, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 16, 2020
• Study Start: October 15, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 15, 2021
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IT (1)