Anti Arrhythmic Therapies and Sudden Cardiac Deaths

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Completed

CT.gov ID

NCT03366181

Collaborator

(none)

500

Enrollment

Location

Actual Duration (Days)

608.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure ICD Sudden Cardiac Death	Device: internal cardioverter defibrillator implant (ICD) Procedure: percutaneous catheter ablation

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Nov 20, 2017

Actual Study Completion Date :

Nov 26, 2017

Arms and Interventions

Arm	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%).

Arm

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%).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

arrhythmic burden [12 months]
authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Raffaele Marfella	Naples		Italy	80128

Sponsors and Collaborators

University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celestino Sardu, MD, MSc, PhD, University of Campania "Luigi Vanvitelli"

ClinicalTrials.gov Identifier:

NCT03366181

Other Study ID Numbers:

10.12.2017.2

First Posted:

Dec 8, 2017

Last Update Posted:

Oct 30, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Oct 30, 2019