Anti Arrhythmic Therapies and Sudden Cardiac Deaths

October 28, 2019 updated by: Celestino Sardu, University of Campania "Luigi Vanvitelli"

New Failing Heart Serum Biomarkers ro Predict Anti Arrhythmic Therapies and Sudden Cardiac Death in Implantable Cardioverter Defibrillators (ICDs) Recipients

Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), ST protein, and adiponectin could be used as predictors for the occurrence of malignant ventricular arrhythmias in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention and treated by catheter ablation for ventricular arrhythmias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80128
        • Raffaele Marfella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

heart failure patients with reduced LVEF (LVEF <35%), and indication to receive a ICD.

Description

Inclusion Criteria:

  • stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction <35%; patients receiving optimal medical therapy.

Exclusion Criteria:

  • NYHA Class I, and IV; co-morbidities which may limit life to <6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
heart failure patients
Device: internal cardioverter defibrillator implant (ICD)
to implant ICD in failing heart subjects with reduced left ventricle ejection fraction (LVEF < 35%).
Procedure: percutaneous catheter ablation
to perform catheter ablation in patients with heart failure and reduced left ventricle ejection fraction (LVEF < 35%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause deaths
Time Frame: 12 months
authors will report all cause of deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry.
12 months
cardiac deaths
Time Frame: 12 months
authors will report cardiac deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry.
12 months
Heart failure hospitalization
Time Frame: 12 months
authors will report heart failure hospitalization by hospital discarge schedules, visits, telephonic interviews.
12 months
ICDs' intervention
Time Frame: 12 months
authors will report ICDs' intervention by hospital discarge schedules, visits, telephonic interviews, and telemetric devices interrogations.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arrhythmic burden
Time Frame: 12 months
authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 26, 2017

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.12.2017.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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