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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03935087

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted May 2, 2019

Study Description

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.

  • Condition or Disease:Heart Failure
  • Intervention/Treatment: Diagnostic Test: two-dimensional echocardiogram
  • Phase: N/A
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 Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 150 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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)
  • Actual Study Start Date: August 2018
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: June 2019
Outcome Measures
  • Primary Outcome Measures: 1. Improvement in left ventricular ejection fraction [ Time Frame: 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: 1. Reduction in left ventricle volumes [ Time Frame: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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
Criteria

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

Contacts and Locations
Contacts
Locations

Italy
Monaldi Hospital
Napoli

Italy, Lecce
"Card. G. Panico" Hospital
Tricase

Italy
Federico Guerra
Ancona

Italy
Policlinico S.Orsola-Malpighi
Bologna

Italy
AO Pugliese-Ciaccio
Catanzaro

Italy
AOU "Maggiore della Carità"
Novara

Sponsors and Collaborators

Azienda Ospedaliera Cardinale G. Panico

More Information
  • Responsible Party: Azienda Ospedaliera Cardinale G. Panico
  • ClinicalTrials.gov Identifier: NCT03935087 History of Changes
  • Other Study ID Numbers: SAVE-ICD
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: May 2, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Heart Failure