Atrial FibrillationHOBIT-FSNCT04560387
Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
A study testing Physician-lead complex program of weight-reducing interventions and Bariatric surgery - sleeve gastrectomy in people with Atrial Fibrillation and Obesity, run by Martin Haluzik at 1 site in Czechia.
Trial summary
Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Obesity
- What is being tested?
- Physician-lead complex program of weight-reducing interventions and Bariatric surgery - sleeve gastrectomy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Sep 2020to 30 Jun 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal or persistent AF scheduled for primary RF ablation
- BMI ≥30 kg/m2
- Age 18-70 years
- Informed consent to the study
Who cannot join
- Previous ablation for AF
- Myocardial infarction, stroke or pulmonary embolism < 3 months prior to inclusion
- left ventricular ejection fraction < 40%
- Left atrium diameter > 55 mm
- Active thyroid disease
- Chronic kidney disease stage IV-V (eGFR < 0.5 ml/s)
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- Chronic liver disease
- Active malignancy
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine
Prague, 14021
Martin Haluzik, Prof. DSc., +420261361111, martin.haluzik@ikem.cz
About this study
Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. The study will evaluate the effect of a complex program aimed at weight reduction on AF burden in subjects after catheter ablation for AF and at least 1st degree obesity. This will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. The weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of >10% of initial body weight. Secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and AF, with the main focus being on low-grade inflammation. The project will help to define the optimal weight-reducing regimen in AF and to tailor the interventions to individual patient needs.
- Conditions
- Atrial Fibrillation, Obesity
- Being tested
- Physician-lead complex program of weight-reducing interventions, Bariatric surgery - sleeve gastrectomy
- Medical subject headings
- Atrial Fibrillation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-lead complex program of weight-reducing interventionsBehavioural
A structured motivational and goal directed program will be used for weight reduction involving physicians, nutritionists, educators and physiotherapists. Initially, based on the input data provided by the patient an individual nutritional plan will be designed with the aim of reducing caloric intake by 10%. Low-intensity aerobic exercise for 30 min will be prescribed 3-times a week with the aim of increasing the frequency to 5-times a week and participants will be offered the possibility to participate in regular physiotherapist-lead group exercises. Patients will be required to maintain a diet and physical activity diary. Regular reviews will be scheduled every 3-6 months according to the actual weight loss.
Bariatric surgery - sleeve gastrectomyProcedure or surgery
Bariatric surgery will be performed based on actual medical indication and independently of patient's participation in the study. Sleeve gastrectomy was selected as the currently most frequent restrictive type of bariatric surgery with a proven efficacy on weight reduction, metabolic status and low-grade inflammation
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Physician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight.
Bariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI > 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI > 35 kg/m2 and a presence of metabolic or other complications). Receives: Behavioral: Physician-lead complex program of weight-reducing interventions; Procedure: Bariatric surgery - sleeve gastrectomy |
| Conservative | No intervention | Routine treatment of obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation burden
Atrial fibrillation burden expressed as % of total monitoring time at final visit
Measured: 18 months
Secondary outcomes (6)
Number of AF episodes on 14-day Holter monitoring
Number of AF episodes on 14-day Holter monitoring
Measured: 18 months
Progressive reduction of AF burden between 12- and 18-month follow up visit
Progressive reduction of AF burden between 12- and 18-month follow up visit
Measured: 18 months
hsCRP
Measured: 18 months
Epicardial adipose tissue volume
Assessed by transthoracic echocardiography
Measured: 18 months
Concentration of atrial natriuretic peptide (ANP)
Measured: 18 months
Concentration of brain natriuretic peptide (BNP)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start21 Sep 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Haluzik
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Martin Haluzik, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560387
- Sponsor's protocol ID
- NU20-02-00190
- Acronym
- HOBIT-FS
- Status last verified
- Oct 2020
- First submitted
- 10 Sep 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stolbova K, Novodvorsky P, Jakubikova I, Dvorakova I, Mraz M, Wichterle D, Kautzner J, Haluzik M. Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol. Adv Ther. 2021 Apr;38(4):2007-2016. doi: 10.1007/s12325-021-01667-0. Epub 2021 Mar 12.
PubMed 33710588
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04560387
- Acronym / sponsor ID
- HOBIT-FS / NU20-02-00190
- Conditions
- Atrial Fibrillation, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Martin HaluzikOther government
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Sep 2020 (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.
Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. The study will evaluate the effect of a complex program aimed at weight reduction on AF burden in subjects after catheter ablation for AF and at least 1st degree obesity. This will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. The weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of >10% of initial body weight. Secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and AF, with the main focus being on low-grade inflammation. The project will help to define the optimal weight-reducing regimen in AF and to tailor the interventions to individual patient needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Behavioral: Physician-lead complex program of weight-reducing interventions, Procedure: Bariatric surgery - sleeve gastrectomyPhysician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight. Bariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI > 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI > 35 kg/m2 and a presence of metabolic or other complications). |
| Conservative | No intervention | –Routine treatment of obesity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Paroxysmal or persistent AF scheduled for primary RF ablation
- BMI ≥30 kg/m2
- Age 18-70 years
- Informed consent to the study
Key exclusion criteria (9 listed)
- Previous ablation for AF
- Myocardial infarction, stroke or pulmonary embolism < 3 months prior to inclusion
- left ventricular ejection fraction < 40%
- Left atrium diameter > 55 mm
- Active thyroid disease
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 |
|---|---|---|
| Physician-lead complex program of weight-reducing interventionsA structured motivational and goal directed program will be used for weight reduction involving physicians, nutritionists, educators and physiotherapists. Initially, based on the input data provided by the patient an individual nutritional plan will be designed with the aim of reducing caloric intake by 10%. Low-intensity aerobic exercise for 30 min will be prescribed 3-times a week with the aim of increasing the frequency to 5-times a week and participants will be offered the possibility to participate in regular physiotherapist-lead group exercises. Patients will be required to maintain a diet and physical activity diary. Regular reviews will be scheduled every 3-6 months according to the actual weight loss. | Behavioural | Interventional |
| Bariatric surgery - sleeve gastrectomyBariatric surgery will be performed based on actual medical indication and independently of patient's participation in the study. Sleeve gastrectomy was selected as the currently most frequent restrictive type of bariatric surgery with a proven efficacy on weight reduction, metabolic status and low-grade inflammation | Procedure or surgery | Interventional |
Primary outcome
Atrial fibrillation burden
Time frame: 18 months
Atrial fibrillation burden expressed as % of total monitoring time at final visit
6 secondary outcomes
Number of AF episodes on 14-day Holter monitoring
Time frame: 18 months
Progressive reduction of AF burden between 12- and 18-month follow up visit
Time frame: 18 months
hsCRP
Time frame: 18 months
Epicardial adipose tissue volume
Time frame: 18 months
Concentration of atrial natriuretic peptide (ANP)
Time frame: 18 months
Concentration of brain natriuretic peptide (BNP)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 33710588Stolbova K, Novodvorsky P, Jakubikova I, Dvorakova I, Mraz M, Wichterle D, Kautzner J, Haluzik M. Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol. Adv Ther. 2021 Apr;38(4):2007-2016. doi: 10.1007/s12325-021-01667-0. Epub 2021 Mar 12.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-lead complex program of weight-reducing interventions and Bariatric surgery - sleeve gastrectomy in people with Atrial Fibrillation and Obesity, run by Martin Haluzik at 1 site in Czechia.
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 9 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristyna Stolbova, MD (+420 728 375 528, kristyna.stolbova@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden (time frame: 18 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 NCT04560387, 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 30 Oct 2020.