ArrythmiaADAPTNCT04776642
Biobank for "Arrhythmia and Conduction Disorders: TowArd Pathophysiology Based Treatment"
An observational study of Arrythmia and Conduction Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia, Conduction Disorder, Pathophysiology
- What is being tested?
- Biobank for Left atrial appendage tissue, Biobank for Blood and Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Dec 2014to Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 27Show fewer
- 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)
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center location AMC
Amsterdam
About this study
Official title: "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.
Read the 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.
- Conditions
- Arrythmia, Conduction Disorder, Pathophysiology
- Being tested
- 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.
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobank for Left atrial appendage tissueOther
Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
Biobank for BloodOther
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.Other
Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
| Study group | Role | What they receive |
|---|---|---|
| MARK_AF | MARKers of ATrial Remodeling in Patietns with Atrial Fibrillation. Patients with paroxysmal and persistent atrial fibrillation undergoing thoracoscopic atrial fibrillation ablation surgery Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Biobank for Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: 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
Measured: 5 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start18 Dec 2014
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joris de Groot, MD, PhD, Principal investigator, Amsterdam UMC - AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776642
- Sponsor's protocol ID
- 2014_054#A201436
- Acronym
- ADAPT
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Arrhythmia and Conduction Disorders: TowArd Pathophysiology Based Treatment" ADAPT Biobank
- ClinicalTrials.gov ID
- NCT04776642
- Acronym / sponsor ID
- ADAPT / 2014_054#A201436
- Conditions
- Arrythmia, Conduction Disorder, Pathophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| MARK_AF | – | 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.MARKers of ATrial Remodeling in Patietns with Atrial Fibrillation. Patients with paroxysmal and persistent atrial fibrillation undergoing thoracoscopic atrial fibrillation ablation surgery |
| INDICO AF | – | Other: Biobank for BloodAtrial 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. |
| PREDICT AF | – | 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.PREDICT AF, Tissue, Blood and biomarkers to predict future Atrial Fibrillation. Patients without a history of atrial fibrillation undergoing cardiothoracic surgery |
| WEIGHTLOSS AF | – | Other: Biobank for Blood, Other: Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.The change of adipose tissue characteristics upon drastic weight loss: Implications for atrial fibrillation. |
| MAD AF | – | Other: Biobank for Blood(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. |
| Adapt Biobank - AF 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.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. |
| Adapt Biobank - blood | – | Other: Biobank for BloodPatients with cardiac arrhythmias who only donate blood for the ADAPT biobank. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (27 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobank for Left atrial appendage tissueBodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias. | Other | Adapt Biobank - AF surgery, MARK_AF, PREDICT AF |
| Biobank for BloodBodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias. | Other | 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.Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias. | Other | Adapt Biobank - AF surgery, MARK_AF, PREDICT AF, WEIGHTLOSS AF |
Primary outcome
(new onset) atrial fibrilation
Time frame: 5 year follow up
obtain a comprehensive collection of patient information and material to facilitate research and gain better insight into the complex pathophysiology of the different arrhythmias
recurrence of cardia arrythmia
Time frame: 5 year follow up
obtain a comprehensive collection of patient information and material to facilitate research and gain better insight into the complex pathophysiology of the different arrhythmias
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joris de Groot, MD, PhD principal investigator
Amsterdam UMC - AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrythmia and Conduction Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Hulsman, Bc RN (31205665653, e.l.hulsman@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(new onset) atrial fibrilation (time frame: 5 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.