Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial (BEAT-IT)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Heart Failure with Preserved Ejection Fraction
• Intervention / Treatment: Procedure: Bariatric surgery strategy

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 Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michiel Rienstra, MD, PhD; Phone Number: +31503611327; Email: m.rienstra@umcg.nl
• Study Contact Backup: Name: Thomas M Gorter, MD, PhD; Email: tm.gorter@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Active, not recruiting
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;
2. Left ventricular ejection fraction ≥40%;
3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;
4. Between 45 and 70 years of age;
5. BMI 32-40 kg/m2;
6. Paroxysmal or persistent AF with a rhythm control strategy;
7. Willing to undergo both treatment strategies;
8. Written informed consent.

Exclusion Criteria:

1. BMI ≥40 kg/m2;
2. BMI <32 kg/m2;
3. Patients unwilling or unable to sign informed consent;
4. More than moderate mitral valve regurgitation/aortic valve regurgitation;
5. More than mild mitral valve stenosis/aortic valve stenosis;
6. Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score;
7. History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, <3 months before inclusion;
8. Scheduled for AF ablation;
9. Complex congenital heart disease;
10. Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders;
11. Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery;
12. Any medical condition that limits life span <2 years;
13. Diseases requiring long term use of anti-inflammatory treatments;
14. The use of medication associated with substantial effects (>5 kg) on body weight.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bariatric surgery strategy; The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme	Procedure: Bariatric surgery strategy; Bariatric surgery including an intensive pre- and postoperative treatment scheme
No Intervention: Standard of Care; The control group will receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	2 years
Emergency room visit or hospitalization for HF	Emergency room visit or hospitalization for HF	2 years
Rate of recurrent AF	Recurrent AF documented on ECG	2 years
Decrease of left ventricular mass	Decrease of ≥30gr of LV mass measured by transthoracic echocardiography	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)	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction	Measuring weight during clinical trial	2 years
Medication changes after surgery	Medication changes after surgery	2 years
Concomitant cardiovascular conditions and relevant comorbidities	Medical history of patient	2 years
Change in left atrial volume	Change in left atrial volume measured by transthoracic echocardiography	2 years
Change in left ventricular diastolic dysfunction	Change in left ventricular diastolic dysfunction measured by transthoracic echocardiography with the definition according to the leading guidelines	2 years
Change in left ventricular ejection fraction	Change in left ventricular ejection fraction measured by transthoracic echocardiography	2 years
Change in right ventricular function	Change in right ventricular function measured by transthoracic echocardiography with the definition according to the leading guidelines	2 years
Change in diameter of epicardial fat	Change in diameter of epicardial fat measured by transthoracic echocardiography	2 years
Healthcare resource use/costs	Measured with the iMedical Consumption Questionnaire (instrument for measuring medical consumption, costs will be estimated by given answers and relation to known costs of the items of medical consumption)	2 years
Health related quality of life / utility	Measured with the 5-level EQ-5D questionnaire (The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)	2 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Rijnstate Hospital
• Investigators: Principal Investigator: Michiel Rienstra, MD, PhD, University Medical Center Groningen; Principal Investigator: Dirk Jan van Veldhuisen, MD, PhD, University Medical Center Groningen; Principal Investigator: Thomas M Gorter, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Bariatric surgery; Heart Failure with Preserved Ejection Fraction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: BEAT-IT trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No