Clinical trial NCT04776642: Biobank for "Arrhythmia and Conduction Disorders: TowArd Pathophysiology Based Treatment"
Official title: "Arrhythmia and Conduction Disorders: TowArd Pathophysiology Based Treatment" ADAPT Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrythmia
Conduction Disorder
Pathophysiology
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

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%.

Primary outcomes:
measure: (new onset) atrial fibrilation
timeFrame: 5 year follow up
measure: recurrence of cardia arrythmia
timeFrame: 5 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center location AMC
Study officials:
affiliation: Amsterdam UMC - AMC
name: Joris de Groot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: