Skip to content

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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03935087
Acronym
SAVE-ICD
Enrollment
150
Registered
2019-05-02
Start date
2018-08-01
Completion date
2019-06-30
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DIAGNOSTIC_TESTtwo-dimensional echocardiogram

two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction

Sponsors

Azienda Ospedaliera Cardinale G. Panico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in left ventricular ejection fractionat enrollment and at 6 months of follow-upDifference between the ejection fraction observed at baseline and that observed at 6 months of follow-up

Secondary

MeasureTime frameDescription
Reduction in left ventricle volumesat enrollment and at 6 months of follow-upDifference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026