Status:

COMPLETED

Role of Sacubitril/Valsartan in the Improvement of Heart Failure With Reduced Ejection Fraction

Lead Sponsor:

Italian Society of Cardiology

Collaborating Sponsors:

Università degli Studi di Brescia

Federico II University

Conditions:

Heart Failure, Left Sided

Left Ventricular Dysfunction

Eligibility:

All Genders

18+ years

Brief Summary

This prospective study evaluates the mechanisms of benefit of sacubitril/valsartan in a population of outpatients with heart failure with reduced ejection fraction, to investigate the relationship bet...

Detailed Description

Therapeutic interventions were made according to a titration protocol in stable optimal medical therapy. Therapy with sacubitril/valsartan was introduced after a 48-hour wash-out of an ACE inhibitor o...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • Ambulatory patients on stable optimal medical therapy
  • History of HF and LVEF ≤ 40%
  • II-III NYHA class
  • EXCLUSION CRITERIA
  • History of congenital heart disease
  • Severe valvular disease or valvular surgery
  • Recent acute coronary syndromes or stroke
  • Poor acoustic windows or missing data.
  • Death or uncompleted follow-up evaluation
  • Cardiac surgery interventions
  • Cardiac resynchronization therapy
  • Coronary or mitral interventions

Exclusion

    Key Trial Info

    Start Date :

    January 13 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 16 2020

    Estimated Enrollment :

    652 Patients enrolled

    Trial Details

    Trial ID

    NCT04397302

    Start Date

    January 13 2019

    End Date

    March 16 2020

    Last Update

    May 28 2020

    Active Locations (1)

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    Frank Lloyd Dini

    Pisa, Italy, 56124

    Role of Sacubitril/Valsartan in the Improvement of Heart Failure With Reduced Ejection Fraction | DecenTrialz