Heart Failure with Preserved Ejection FractionBEAT-ITNCT06065124
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
A study testing Bariatric surgery strategy in people with Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
The goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Heart Failure with Preserved Ejection Fraction, Atrial Fibrillation
- What is being tested?
- Bariatric surgery strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jul 2024to Oct 2027
- Phase
- Interventional
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;
- Left ventricular ejection fraction ≥40%;
- HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;
- Between 45 and 70 years of age;
- BMI 32-40 kg/m2;
- Paroxysmal or persistent AF with a rhythm control strategy;
- Willing to undergo both treatment strategies;
- Written informed consent.
Who cannot join
- BMI ≥40 kg/m2;
- BMI <32 kg/m2;
- Patients unwilling or unable to sign informed consent;
- More than moderate mitral valve regurgitation/aortic valve regurgitation;
- More than mild mitral valve stenosis/aortic valve stenosis;
- Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score;
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- History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, <3 months before inclusion;
- Scheduled for AF ablation;
- Complex congenital heart disease;
- Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders;
- Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery;
- Any medical condition that limits life span <2 years;
- Diseases requiring long term use of anti-inflammatory treatments;
- The use of medication associated with substantial effects (>5 kg) on body weight.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas M Gorter, MD, PhD contact
Netherlands2 sites, 1 recruiting
- Active, not recruiting
Rijnstate Hospital
Arnhem, Gelderland, 6815AD
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ
About this study
Official title: Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial
The goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.
Read the detailed description
The primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for HF within 2 years, 3) recurrent ECG-documented AF within 2 years, 4) decrease of ≥30gr of left ventricular (LV) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- Being tested
- Bariatric surgery strategy
- Keywords
- Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction, Bariatric surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgery strategyProcedure or surgery
Bariatric surgery including an intensive pre- and postoperative treatment scheme
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery strategy | Active comparator | The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme Receives: Procedure: Bariatric surgery strategy |
| Standard of Care | No intervention | The control group will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical endpoint
The hierarchical occurrence of: 1) All-cause mortality; 2) Emergency room visit or hospitalization for HF; 3) Recurrent ECG-documented AF; 4) Decrease of ≥30gr of LV mass on transthoracic echocardiography; 5) Improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (Scores are transformed to a range of 0-100, in which higher scores reflect better health status)
Measured: 2 years
Secondary outcomes (5)
All-cause mortality
All-cause mortality
Measured: 2 years
Emergency room visit or hospitalization for HF
Emergency room visit or hospitalization for HF
Measured: 2 years
Rate of recurrent AF
Recurrent AF documented on ECG
Measured: 2 years
Decrease of left ventricular mass
Decrease of ≥30gr of LV mass measured by transthoracic echocardiography
Measured: 2 years
Kansas City Cardiomyopathy Questionnaire improvement
Improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (scores are transformed to a range of 0-100, in which higher scores reflect better health status)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jul 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure with Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Model description
- Multicentre, prospective, randomized controlled, open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Sponsor
- Investigators
- Michiel Rienstra, MD, PhD, Principal investigator, University Medical Center GroningenDirk Jan van Veldhuisen, MD, PhD, Principal investigator, University Medical Center GroningenThomas M Gorter, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065124
- Sponsor's protocol ID
- BEAT-IT trial
- Acronym
- BEAT-IT
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial
- ClinicalTrials.gov ID
- NCT06065124
- Acronym / sponsor ID
- BEAT-IT / BEAT-IT trial
- Keywords
- Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 3 Oct 2023 (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 goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.
Detailed description
The primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for HF within 2 years, 3) recurrent ECG-documented AF within 2 years, 4) decrease of ≥30gr of left ventricular (LV) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, prospective, randomized controlled, open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery strategy | Active comparator | Procedure: Bariatric surgery strategyThe intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme |
| Standard of Care | No intervention | –The control group will receive standard of care |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;
- Left ventricular ejection fraction ≥40%;
- HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;
- Between 45 and 70 years of age;
- BMI 32-40 kg/m2;
Key exclusion criteria (14 listed)
- BMI ≥40 kg/m2;
- BMI <32 kg/m2;
- Patients unwilling or unable to sign informed consent;
- More than moderate mitral valve regurgitation/aortic valve regurgitation;
- More than mild mitral valve stenosis/aortic valve stenosis;
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 |
|---|---|---|
| Bariatric surgery strategyBariatric surgery including an intensive pre- and postoperative treatment scheme | Procedure or surgery | Bariatric surgery strategy |
Primary outcome
Hierarchical endpoint
Time frame: 2 years
The hierarchical occurrence of: 1) All-cause mortality; 2) Emergency room visit or hospitalization for HF; 3) Recurrent ECG-documented AF; 4) Decrease of ≥30gr of LV mass on transthoracic echocardiography; 5) Improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (Scores are transformed to a range of 0-100, in which higher scores reflect better health status)
5 secondary outcomes
All-cause mortality
Time frame: 2 years
Emergency room visit or hospitalization for HF
Time frame: 2 years
Rate of recurrent AF
Time frame: 2 years
Decrease of left ventricular mass
Time frame: 2 years
Kansas City Cardiomyopathy Questionnaire improvement
Time frame: 2 years
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 1 Apr 2025.
- 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.
Thomas M Gorter, MD, PhD contact
Michiel Rienstra, MD, PhD principal investigator
University Medical Center Groningen
Dirk Jan van Veldhuisen, MD, PhD principal investigator
University Medical Center Groningen
Thomas M Gorter, MD, PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery strategy in people with Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation, run by University Medical Center Groningen at 2 sites 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 8 inclusion and 14 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Michiel Rienstra, MD, PhD (+31503611327, m.rienstra@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical endpoint (time frame: 2 years). 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 1 Apr 2025.