Anti Arrhythmic Therapies and Sudden Cardiac Deaths

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366181
• Other study ID #: 10.12.2017.2
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: November 26, 2017

Study information

• Verified date: October 2019
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 26, 2017
• Est. primary completion date: November 20, 2017
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• ICD
• Sudden Cardiac Death

Intervention

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%).

Locations

Country	Name	City	State
Italy	Raffaele Marfella	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause deaths	authors will report all cause of deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry.	12 months
Primary	cardiac deaths	authors will report cardiac deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry.	12 months
Primary	Heart failure hospitalization	authors will report heart failure hospitalization by hospital discarge schedules, visits, telephonic interviews.	12 months
Primary	ICDs' intervention	authors will report ICDs' intervention by hospital discarge schedules, visits, telephonic interviews, and telemetric devices interrogations.	12 months
Secondary	arrhythmic burden	authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations.	12 months