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

Primary Purpose

Heart Failure With Preserved Ejection Fraction, Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bariatric surgery strategy
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction, Bariatric surgery

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • Rijnstate Hospital
  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Bariatric surgery strategy

Standard of Care

Arm Description

The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme

The control group will receive standard of care

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2023
Last Updated
September 26, 2023
Sponsor
University Medical Center Groningen
Collaborators
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06065124
Brief Title
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Acronym
BEAT-IT
Official Title
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure With Preserved Ejection Fraction - Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction, Atrial Fibrillation
Keywords
Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, prospective, randomized controlled, open-label clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bariatric surgery strategy
Arm Type
Active Comparator
Arm Description
The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The control group will receive standard of care
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery strategy
Intervention Description
Bariatric surgery including an intensive pre- and postoperative treatment scheme
Primary Outcome Measure Information:
Title
Hierarchical endpoint
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
2 years
Title
Emergency room visit or hospitalization for HF
Description
Emergency room visit or hospitalization for HF
Time Frame
2 years
Title
Rate of recurrent AF
Description
Recurrent AF documented on ECG
Time Frame
2 years
Title
Decrease of left ventricular mass
Description
Decrease of ≥30gr of LV mass measured by transthoracic echocardiography
Time Frame
2 years
Title
Kansas City Cardiomyopathy Questionnaire improvement
Description
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)
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Weight reduction
Description
Measuring weight during clinical trial
Time Frame
2 years
Title
Medication changes after surgery
Description
Medication changes after surgery
Time Frame
2 years
Title
Concomitant cardiovascular conditions and relevant comorbidities
Description
Medical history of patient
Time Frame
2 years
Title
Change in left atrial volume
Description
Change in left atrial volume measured by transthoracic echocardiography
Time Frame
2 years
Title
Change in left ventricular diastolic dysfunction
Description
Change in left ventricular diastolic dysfunction measured by transthoracic echocardiography with the definition according to the leading guidelines
Time Frame
2 years
Title
Change in left ventricular ejection fraction
Description
Change in left ventricular ejection fraction measured by transthoracic echocardiography
Time Frame
2 years
Title
Change in right ventricular function
Description
Change in right ventricular function measured by transthoracic echocardiography with the definition according to the leading guidelines
Time Frame
2 years
Title
Change in diameter of epicardial fat
Description
Change in diameter of epicardial fat measured by transthoracic echocardiography
Time Frame
2 years
Title
Healthcare resource use/costs
Description
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)
Time Frame
2 years
Title
Health related quality of life / utility
Description
Measured with the 5-level EQ-5D questionnaire (The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michiel Rienstra, MD, PhD
Phone
+31503611327
Email
m.rienstra@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas M Gorter, MD, PhD
Email
tm.gorter@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Rienstra, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Jan van Veldhuisen, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas M Gorter, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815AD
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

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