Atrial FibrillationSORT-AFNCT02064114
SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients
A study testing Intervention group in people with Atrial Fibrillation and Obesity, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in Germany.
Trial summary
Study hypothesis: Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation. Study design: A prospective randomized, open-label clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Obesity, Sleep Apnea
- What is being tested?
- Intervention group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2014to 16 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Overweight with a BMI ≥ 30
- Obtained written informed consent
- Symptomatic atrial fibrillation with indication for ablation
Who cannot join
- Age <18 years
- Permanent atrial fibrillation (failed Cardioversion or episode duration > 12 months)
- Previous surgical or interventional therapy of atrial fibrillation
- BMI > 40
- Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- History of hemorrhagic diathesis or other coagulopathies
Show all 13Show fewer
- Contraindications for oral anticoagulation
- Hyper- or hypothyroidism
- Drug or chronic alcohol abuse
- Has any condition that would make participation not be in the best interest of the subject
- Incompliance
- Unable to perform athletic exercise due to disease or disability
- Resident outside Hamburg
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Herzzentrum der Universität zu Köln
Cologne
Asklepios ST. Georg
Hamburg, 20246
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitäres Herzzentrum Lübeck
Lübeck, Schleswig-Holstein, 23562
About this study
Official title: Supervised Obesity Reduction Trial for AF Ablation Patients
Study hypothesis:
Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation.
Study design:
A prospective randomized, open-label clinical trial.
Read the detailed description
Study protocol:
The purpose of this study is to proof a professional care of overweight patients with symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial fibrillation, especially obstructive sleep apnea and hypertension.
There is a 1:1 randomization. In the intervention group, patients are followed up in a 6-month intensive care after atrial fibrillation ablation. During the follow up time patients will visit the nutritional advice every two weeks for 6 months.
The Follow-up in the control group is standard of care. At baseline, a screening test for obstructive sleep apnea and arterial hypertension will be performed as standard care.
The documentation of atrial fibrillation after ablation is made possible by the implantation of an event recorder before atrial fibrillation ablation.
Follow up:
A follow-up will be performed after 3,6 and 12 months in both groups. Patients in the intervention group will be followed-up every 2 weeks in the first 6 months.
- Conditions
- Atrial Fibrillation, Obesity, Sleep Apnea
- Being tested
- Intervention group, control group
- Keywords
- BMI >40
- Medical subject headings
- Atrial Fibrillation, Obesity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupProcedure or surgery
Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.
control groupProcedure or surgery
Followed for a period of 3,6 and 12 months after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure. Receives: Procedure: Intervention group |
| control group | Active comparator | conventional treatment, followed for a period of 3,6 and 12 months after the procedure. Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation
AF burden is defined as overall percentage of AF during the observed period.
Measured: 12 months
Secondary outcomes (9)
AF burden between 0 and 12 months after first AF ablation
Measured: 12 months
AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation
Measured: 12 months
Freedom of AF (after 3 months blanking period)
Measured: 12 months
Time to first recurrent AF (after 3 months blanking period)
Measured: 12 months
Body Mass Index (BMI) change from BL to 12 months
Measured: 12 months
Exercise capacity change from BL to 12 months
Measured: 12 months
Mean blood pressure change from BL to 12 months
Measured: 12 months
Number of repeated AF ablation procedures
Measured: 12 months
Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startJan 2014
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- Christian Meyer, Principal investigator, University Heart Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064114
- Sponsor's protocol ID
- PV4300
- Acronym
- SORT-AF
- Status last verified
- Sep 2022
- First submitted
- 13 Feb 2014
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gessler N, Willems S, Steven D, Aberle J, Akbulak RO, Gosau N, Hoffmann BA, Meyer C, Sultan A, Tilz R, Vogler J, Wohlmuth P, Scholz S, Gunawardene MA, Eickholt C, Luker J. Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial. Europace. 2021 Oct 9;23(10):1548-1558. doi: 10.1093/europace/euab122.
PubMed 33895833
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Obesity Reduction Trial for AF Ablation Patients
- ClinicalTrials.gov ID
- NCT02064114
- Acronym / sponsor ID
- SORT-AF / PV4300
- Conditions
- Atrial Fibrillation, Obesity, Sleep Apnea
- Keywords
- BMI >40
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- Jan 2014 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 17 Feb 2014 (estimated)
- 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.
Study hypothesis:
Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation.
Study design:
A prospective randomized, open-label clinical trial.
Detailed description
Study protocol:
The purpose of this study is to proof a professional care of overweight patients with symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial fibrillation, especially obstructive sleep apnea and hypertension.
There is a 1:1 randomization. In the intervention group, patients are followed up in a 6-month intensive care after atrial fibrillation ablation. During the follow up time patients will visit the nutritional advice every two weeks for 6 months.
The Follow-up in the control group is standard of care. At baseline, a screening test for obstructive sleep apnea and arterial hypertension will be performed as standard care.
The documentation of atrial fibrillation after ablation is made possible by the implantation of an event recorder before atrial fibrillation ablation.
Follow up:
A follow-up will be performed after 3,6 and 12 months in both groups. Patients in the intervention group will be followed-up every 2 weeks in the first 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Intervention groupStart of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure. |
| control group | Active comparator | Procedure: control groupconventional treatment, followed for a period of 3,6 and 12 months after the procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Overweight with a BMI ≥ 30
- Obtained written informed consent
- Symptomatic atrial fibrillation with indication for ablation
Key exclusion criteria (13 listed)
- Age <18 years
- Permanent atrial fibrillation (failed Cardioversion or episode duration > 12 months)
- Previous surgical or interventional therapy of atrial fibrillation
- BMI > 40
- Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
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 |
|---|---|---|
| Intervention groupStart of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure. | Procedure or surgery | Intervention group |
| control groupFollowed for a period of 3,6 and 12 months after the procedure. | Procedure or surgery | control group |
Primary outcome
The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation
Time frame: 12 months
AF burden is defined as overall percentage of AF during the observed period.
9 secondary outcomes
AF burden between 0 and 12 months after first AF ablation
Time frame: 12 months
AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation
Time frame: 12 months
Freedom of AF (after 3 months blanking period)
Time frame: 12 months
Time to first recurrent AF (after 3 months blanking period)
Time frame: 12 months
Body Mass Index (BMI) change from BL to 12 months
Time frame: 12 months
Exercise capacity change from BL to 12 months
Time frame: 12 months
Mean blood pressure change from BL to 12 months
Time frame: 12 months
Number of repeated AF ablation procedures
Time frame: 12 months
Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 33895833Gessler N, Willems S, Steven D, Aberle J, Akbulak RO, Gosau N, Hoffmann BA, Meyer C, Sultan A, Tilz R, Vogler J, Wohlmuth P, Scholz S, Gunawardene MA, Eickholt C, Luker J. Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial. Europace. 2021 Oct 9;23(10):1548-1558. doi: 10.1093/europace/euab122.
- 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. This study is not recruiting at the moment.
Christian Meyer principal investigator
University Heart Center Hamburg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Atrial Fibrillation and Obesity, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in Germany.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064114, which also lists 1 linked publication.
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 19 Sep 2022.