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

A

Azienda Ospedaliera Cardinale G. Panico

Status

Unknown

Conditions

Heart Failure

Treatments

Diagnostic Test: two-dimensional echocardiogram

Study type

Observational

Funder types

Other

Identifiers

NCT03935087
SAVE-ICD

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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