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Recruiting NCT04776642

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

— Observational Arrythmia Conduction Disorder Pathophysiology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biobank for Left atrial appendage tissue, Biobank for Blood, Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat..
Who it may be relevant to
Registry conditions: Arrythmia, Conduction Disorder, Pathophysiology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • (new onset) atrial fibrilation [Time frame: 5 year follow up]
  • recurrence of cardia arrythmia [Time frame: 5 year follow up]

Eligibility criteria

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%.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Amsterdam University Medical Center location AMC — Amsterdam

Identifiers

NCT: NCT04776642 · 2014_054#A201436

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗