Biobank for "Arrhythmia and Conduction Disorders: TowArd Pathophysiology Based Treatment"

Arrythmia Clinical Trial

— ADAPT  

Official title:

"Arrhythmia and Conduction Disorders: TowArd Pathophysiology Based Treatment" ADAPT Biobank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776642
• Other study ID #: 2014_054#A201436
• Status: Recruiting
• Start date: December 18, 2014
• Est. completion date: January 2030

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Elise Hulsman, Bc RN
• Phone: 31205665653
• Email: e.l.hulsman[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The 'ADAPT' Biobank is a collection of body material and data from patients with or at risk of cardiac arrhythmias who underwent or will undergo (non-) invasive treatment for this disease. Its main objective is to obtain a comprehensive collection of patient information and material to facilitate research and gain better insight into the complex pathophysiology of the different arrhythmias, the multifactorial process, the heterogeneity in clinical presentation, and prognosis.

Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.

Description:

The pathophysiological process of many cardiac arrhythmias is complex because of its multifactorial character. Despite extensive research that has already been performed in the field of electrophysiology the exact pathophysiological process of the different arrhythmias remains incompletely understood. The ability to identify subgroups of patients within a population with the same type of arrhythmia that can benefit from a specific treatment strategy might provide more individualized therapeutic opportunities, improve prognostication or provide preventive opportunities in patient with cardiac arrhythmias. Biobanks can make a valuable contribution to the development of diagnostic, preventive and therapeutic methods. More insights into the correlations between genes, environmental factors and susceptibility to illness may be of great value. The 'ADAPT' Biobank has been designed to establish a systematic and qualitative collection of bodily materials for future research in the cardiovascular field. The Biobank includes bodily material of patients with cardiac arrhythmias undergoing (non-) invasive treatment or control patients undergoing cardiothoracic surgery. Clinical data related to the cardiac arrhythmic disease is recorded. The data and samples will be linked to the participants' medical records to allow longitudinal follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients visiting the AMC outpatient clinic

• Patients included in an ongoing clinical trial linked to this biobank. Studies are listed under point "Groups and interventions" and include:

• MARK AF

• INDICO AF

• PREDICT AF

• WEIGHTLOSS AF

• MAD AF

• Patients included in future clinical trial linked to this biobank. Studies may be linked to this biobank that investigates prevalent or incident cardiac arrhythmias.

• Cardiac arrhtymias are defined as

• Supraventricular tachycardia, among which the most common are:

• Atrial Fibrillation (AF)

• Atrial Tachycardia (AT)

• Atrial Flutter (AFL)

• Atrioventricular Nodal Reentrant Tachycardia (AVNRT)

• Atrioventricular Reentrant Tachycardia (AVRT)

• Ventricular tachycardia, among which the most common are:

• Ventricular Tachycardia (VT)

• Ventricular Flutter (VFL)

• Ventricular Fibrillation (VF)

• Bradycardia:

• Sinus Node Dysfunction

• AV Node Dysfunction

• Interventricular Conduction Disorder

• Arrhythmogenic cardiomyopathies, among which the most common are:

• Dilated Cardiomyopathy

• Restrictive Cardiomyopathy

• Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Exclusion criteria (shared for all studies):

• Age < 18

• Unable or unwilling to comply with study procedures

• Pregnancy or of childbearing potential without adequate contraception

• NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Conduction Disorder
• Pathophysiology

Intervention

Other:
• Biobank for Left atrial appendage tissue
Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
• Biobank for Blood
Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
• Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.
Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(new onset) atrial fibrilation	obtain a comprehensive collection of patient information and material to facilitate research and gain better insight into the complex pathophysiology of the different arrhythmias	5 year follow up
Primary	recurrence of cardia arrythmia	obtain a comprehensive collection of patient information and material to facilitate research and gain better insight into the complex pathophysiology of the different arrhythmias	5 year follow up