Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan

• Conditions: Heart Failure

• Registration Number: NCT03935087
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

Brief Summary

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.

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 Timeline

• Study Start: 2018-08-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-02
• Last Update Posted: 2019-05-02
• Primary Completion: 2019-05-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in left ventricular ejection fraction	at enrollment and at 6 months of follow-up	Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up

Secondary Outcome Measures

Name	Time	Method
Reduction in left ventricle volumes	at enrollment and at 6 months of follow-up	Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up

Trial Locations

Locations (6)

AO Pugliese-Ciaccio; 🇮🇹 Catanzaro, Italy

Federico Guerra; 🇮🇹 Ancona, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

Monaldi Hospital; 🇮🇹 Napoli, Italy

AOU "Maggiore della Carità"; 🇮🇹 Novara, Italy

"Card. G. Panico" Hospital; 🇮🇹 Tricase, Lecce, Italy