NCT03935087

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

April 30, 2019

Last Update Submit

April 30, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reduction in left ventricle volumes

    at enrollment and at 6 months of follow-up

Interventions

two-dimensional echocardiogramDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

"Card. G. Panico" Hospital

Tricase, Lecce, 73039, Italy

RECRUITING

Federico Guerra

Ancona, Italy

RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

RECRUITING

AO Pugliese-Ciaccio

Catanzaro, 88100, Italy

RECRUITING

Monaldi Hospital

Napoli, Italy

RECRUITING

AOU "Maggiore della Carità"

Novara, 28100, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 2, 2019

Study Start

August 1, 2018

Primary Completion

May 31, 2019

Study Completion

June 30, 2019

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

IT(6)