To evaluate the effects of a bariatric surgery strategy on 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.
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
- Gastrointestinal therapeutic procedures
Synonym
Health condition
obesitas, boezemfibrilleren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The hierarchical occurrence of: 1) all-cause mortality within 2 year, 2)
emergency room visit or hospitalization for HF within 2 year, 3) recurrent
ECG-documented AF, 4) >=30gr decrease in left ventricular (LV) mass at 2 year,
and 5) improvement of >=5 points on the Kansas City Cardiomyopathy Questionnaire
(KCCQ) at 2 year.
Most endpoints refer to objective endpoints (i.e. mortality, decrease of >=30gr
of LV mass and improvement of >=5 points on the KCCQ). An independent endpoint
committee consisting of a heart failure cardiologist and an electrophysiologist
blinded for baseline characteristics and patient* allocation will assess the
other primary endpoints and will allocate whether the endpoint is adequately
scored as being hospitalization/ER visit for heart failure and recurrent atrial
fibrillation. In case of discrepancy, a third independent cardiologist will be
asked.
Secondary outcome
1. To study the effect of bariatric surgery on all individual items of the
hierarchical endpoint.
2. To study the effect of bariatric surgery on echocardiographic parameters
(eg. LVEF, LV diastolic function, left atrial size, right ventricular function,
amount of epicardial fat) at 2 years.
Background summary
Obesity is amongst the most prominent and robust risk factors of heart failure
(HF) with preserved or mildly reduced left ventricular ejection fraction
(LVEF). Obesity is also highly prevalent in patients already diagnosed with HF.
Once present, obesity is associated with adverse myocardial remodelling,
reduced exercise capacity, progression of atrial fibrillation (AF) and impaired
cardiac haemodynamics, compared to non-obese patients with a similar HF type.
Obesity is therefore suggested to play a pivotal role in the pathophysiology of
HF with preserved or mildly reduced LVEF and durable significant weight loss
may reduce the negative impact of adiposity on the heart in these patients.
However, the treatment of obesity is notoriously difficult and among all
treatment options, bariatric surgery is the most durable option. Bariatric
surgery is the recommended choice for patients with class III obesity (body
mass index [BMI] >40 kg/m2) as it significantly improves long-term
obesity-related outcomes, including mortality. Bariatric surgery is also
performed in patients with BMI <40 kg/m2 who have additional relevant
obesity-related conditions, mainly type 2 diabetes mellitus. Bariatric surgery
is primarily performed in the context of reducing the risk for the development
of an obesity-related cardiovascular disease, such as HF. Indeed, it was shown
that bariatric surgery significantly reduced the risk of both incident HF and
incident AF. However, bariatric surgery is also suggested to be a promising
therapy for obese patients already diagnosed with HF and/or AF, but no
randomized evaluation of the beneficial effects of bariatric surgery in obese
patients with HF and/or AF has been performed so far. Hence, bariatric surgery
as a treatment for obese patients with HF and/or AF currently has no specific
recommendation in the guidelines. We hypothesize that obese patients with HF
with preserved or mildly reduced LVEF in combination with AF may also benefit
from significant and durable weight loss following bariatric surgery.
Study objective
To evaluate the effects of a bariatric surgery strategy on 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.
Study design
Multicentre, prospective, randomized controlled, open-label clinical trial
Intervention
An Intervention group receiving bariatric surgery will be compared to a Control
group receiving standard of care. Both groups will be randomized in a 1:1
fashion.
Study burden and risks
Patients in the Intervention group will be exposed to increased risk on
peri-procedural complications (e.g. bleeding and wound infection) and major
complications following bariatric surgery (e.g. including anastomotic leakage,
thrombosis and pulmonary embolism). The total incidence of minor complications
(i.e. Clavien Dindo class I-II) in 2019 in The Netherlands was 2.3%. For severe
complications (i.e. Clavien Dindo class III-V), the incidence rate in 2019 in
The Netherlands was 1.9%. The incidence of severe complications was 1.6% for
age <65 years and 2.7% for age >=65 years. Overall mortality rate following
bariatric surgery (i.e. Clavien Dindo class V) in The Netherlands was 0.0% in
2019 (DATO Bariatric Surgery Report 2019
https://dica.nl/jaarrapportage-2019/dato). Of course the patients in the
Control group are not exposed to this peri-procedural risk. However, there are
currently no therapies available that have been proven beneficial in reducing
mortality and morbidity for patients with HF with preserved or mildly reduced
LVEF. With this study design, the beneficial effects of bariatric surgery can
be evaluated. If bariatric surgery is indeed beneficial in terms of clinical
endpoints, cardiac parameters and functional status, bariatric surgery for
obese patients with HF with preserved of mildly reduced LVEF may be a valuable
treatment option in the future to improve their prognosis and functional
status.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
1. Signs and symptoms of HF according to the European Society of Cardiology
guidelines.
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
life-style 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78618.042.21 |