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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pathophysiology; Arrythmia; Conduction Disorder
• Intervention / Treatment: Other: Biobank for Left atrial appendage tissue; Other: Biobank for Blood; Other: Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Elise Hulsman, Bc RN; Phone Number: 31205665653; Email: e.l.hulsman@amsterdamumc.nl
• Study Contact Backup: Name: Joris de Groot, MD, PhD; Phone Number: 310205666555; Email: j.r.degroot@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Center location AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with cardiac arrhythmia and are treated in the AMC Heart Center are eligible to donate blood or other bodily material for the 'ADAPT' Biobank. Patient are asked to participate in the 'ADAPT' Biobank during outpatient clinic visits or prior to treatment for their arrhythmia.

Description

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%.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MARK_AF; MARKers of ATrial Remodeling in Patietns with Atrial Fibrillation. Patients with paroxysmal and persistent atrial fibrillation undergoing thoracoscopic atrial fibrillation ablation surgery	Other: Biobank for Left atrial appendage tissue; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: 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.
INDICO AF; Atrial Fibrillation in Patients With an Implantable Cardioverter Defibrillator and Coronary Artery Disease. Investigate the incidence of new-onset AF in patients with coronairy artery disease and an impaired LVEF, who will receive a single chamber ICD as primary prevention for sudden cardiac death.	Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
PREDICT AF; PREDICT AF, Tissue, Blood and biomarkers to predict future Atrial Fibrillation. Patients without a history of atrial fibrillation undergoing cardiothoracic surgery	Other: Biobank for Left atrial appendage tissue; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: 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.
WEIGHTLOSS AF; The change of adipose tissue characteristics upon drastic weight loss: Implications for atrial fibrillation.	Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: 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.
MAD AF; (123I-mIBG And Defibrillation for Atrial Fibrillation) Enhanced sympathetic activity as a mechanism of Atrial Fibrillation. Patients will undergo 123I-mIBG scintigraphy within 7 days before and six week after an elective cardioversion is performed.	Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
Adapt Biobank - AF surgery; Patients with Atrial Fibrillation who only donate blood and tissue for the biobank. Patients undergo thorascopic surgery, LAA will be amputated, blood will be collected.	Other: Biobank for Left atrial appendage tissue; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.; Other: 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.
Adapt Biobank - blood; Patients with cardiac arrhythmias who only donate blood for the ADAPT biobank.	Other: Biobank for Blood; Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Joris de Groot, MD, PhD, Amsterdam UMC - AMC

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2014
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease
• Other Study ID Numbers: 2014_054#A201436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No