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

Heart Failure Clinical Trial

— SAVE-ICD  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935087
• Other study ID #: SAVE-ICD
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2019
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• two-dimensional echocardiogram
two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction

Locations

Country	Name	City	State
Italy	Federico Guerra	Ancona
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	AO Pugliese-Ciaccio	Catanzaro
Italy	Monaldi Hospital	Napoli
Italy	AOU "Maggiore della Carità"	Novara
Italy	"Card. G. Panico" Hospital	Tricase	Lecce

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Cardinale G. Panico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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