Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

Atrial Fibrillation Clinical Trial

— BEAT-IT  

Official title:

Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure With Preserved Ejection Fraction - Intervention Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06065124
• Other study ID #: BEAT-IT trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 2027

Study information

• Verified date: September 2023
• Source: University Medical Center Groningen
• Contact: Michiel Rienstra, MD, PhD
• Phone: +31503611327
• Email: m.rienstra[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Procedure:
• Bariatric surgery strategy
Bariatric surgery including an intensive pre- and postoperative treatment scheme

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight reduction	Measuring weight during clinical trial	2 years
Other	Medication changes after surgery	Medication changes after surgery	2 years
Other	Concomitant cardiovascular conditions and relevant comorbidities	Medical history of patient	2 years
Other	Change in left atrial volume	Change in left atrial volume measured by transthoracic echocardiography	2 years
Other	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
Other	Change in left ventricular ejection fraction	Change in left ventricular ejection fraction measured by transthoracic echocardiography	2 years
Other	Change in right ventricular function	Change in right ventricular function measured by transthoracic echocardiography with the definition according to the leading guidelines	2 years
Other	Change in diameter of epicardial fat	Change in diameter of epicardial fat measured by transthoracic echocardiography	2 years
Other	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
Other	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
Primary	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	All-cause mortality	All-cause mortality	2 years
Secondary	Emergency room visit or hospitalization for HF	Emergency room visit or hospitalization for HF	2 years
Secondary	Rate of recurrent AF	Recurrent AF documented on ECG	2 years
Secondary	Decrease of left ventricular mass	Decrease of =30gr of LV mass measured by transthoracic echocardiography	2 years
Secondary	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