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

NCT04776642 | Recruiting

• 1 other identifier: 2014_054#A201436
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrythmia; Conduction Disorder; Pathophysiology

Outcome Measures

Primary Outcomes (2)

• (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

Study Arms (7)

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; Other: Biobank for Blood; Other: Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.

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

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; Other: Biobank for Blood; Other: Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.

WEIGHTLOSS AF

The change of adipose tissue characteristics upon drastic weight loss: Implications for atrial fibrillation.

Other: Biobank for Blood; Other: Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.

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

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; Other: Biobank for Blood; Other: Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.

Adapt Biobank - blood

Patients with cardiac arrhythmias who only donate blood for the ADAPT biobank.

Other: Biobank for Blood

Interventions

Biobank for Left atrial appendage tissue OTHER

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

Adapt Biobank - AF surgery; MARK_AF; PREDICT AF

Biobank for Blood OTHER

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

Adapt Biobank - AF surgery; Adapt Biobank - blood; INDICO AF; MAD AF; MARK_AF; PREDICT AF; WEIGHTLOSS AF

Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat. OTHER

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

Adapt Biobank - AF surgery; MARK_AF; PREDICT AF; WEIGHTLOSS AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Center location AMC

Amsterdam, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* left atrial appendage tissue * blood * one or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Biological Specimen Banks; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Joris de Groot, MD, PhD

  Amsterdam UMC - AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Hulsman, Bc RN

CONTACT

31205665653; e.l.hulsman@amsterdamumc.nl

Joris de Groot, MD, PhD

CONTACT

310205666555; j.r.degroot@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: December 18, 2014
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)