Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan (SAVE-ICD)

Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan and Potential Impact on ICD Implant Rates for Primary Prevention of Sudden Cardiac Death (SAVE-ICD)

The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: two-dimensional echocardiogram

Detailed Description

Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • Federico Guerra
    • Contact: Federico Guerra, MD; Phone Number: +393333862467; Email: matziacc@libero.it
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico S.Orsola-Malpighi
  • Catanzaro, Italy, 88100
    • Recruiting
    • AO Pugliese-Ciaccio
  • Napoli, Italy
    • Recruiting
    • Monaldi Hospital
    • Contact: Ernesto Ammendola, MD; Phone Number: +393382841171; Email: ammendolaernesto@libero.it
  • Novara, Italy, 28100
    • Recruiting
    • AOU "Maggiore della Carità"
    • Contact: Gabriele Dell'Era, MD; Phone Number: +393296575400; Email: gdellera@gmail.com
  • Lecce
    • Tricase, Lecce, Italy, 73039
      • Recruiting
      • "Card. G. Panico" Hospital
      • Contact: Pietro Palmisano, MD; Phone Number: +390833773111; Email: dr.palmisano@libero.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure, left ventricular systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death, and undergoing therapy with Sacubitril/Valsartan according to current Guidelines

Description

Inclusion Criteria:

• heart failure
• left ventricular systolic dysfunction
• carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death
• undergoing therapy with Sacubitril/Valsartan according to current Guidelines

Exclusion Criteria:

• age <18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in left ventricular ejection fraction	Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up	at enrollment and at 6 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in left ventricle volumes	Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up	at enrollment and at 6 months of follow-up

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Cardinale G. Panico

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): May 31, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (ACTUAL): May 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SAVE-ICD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No