To assess the prevalence of subclinical AF in obesity patients by using different contemporary AF-detection applications (primary objective). To investigate the potential role of GLS as a parameter to predict presence of AF in obesity patients (…
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the proportion of obesity patients with AF as
detected by 1 week heart rhythm registration with an AF-detection patch (before
bariatric surgery).
In 40 obesity patients with an increased CHA2DS2VASc-score who received both an
AF-detection patch and an ILR, the proportions of patients with AF as detected
by 1 week heart rhythm registration with the patch or 3 months with the ILR
(before bariatric surgery) will also be explored. Results will be presented in
a descriptive manner.
GLS (mean ± standard deviation) at baseline (before bariatric surgery) will be
compared between obesity patients with versus without AF as identified by the
AF-detection patch and/or ILR.
Secondary outcome
Change in the proportion of obesity patients with any AF episode as detected by
an AF-detection patch between study onset (1 week monitoring before surgery)
and one year after surgery (1 week monitoring).
Change in the proportion of obesity patients with any AF episode as detected by
an ILR between study onset (3 months monitoring before surgery) and in the
period of 9 to 12 months after surgery (3 months monitoring).
Background summary
Obesity is a global epidemic. Obesity is associated with an increased risk of
atrial fibrillation (AF). AF is the most common sustained cardiac rhythm
disorder in humans with potentially life threatening complications. Detection
of subclinical AF in obesity patients would allow initiation of proper therapy
and follow-up. However, to financially and logistically permit screening of
subjects on AF, subjects with the highest risk of having AF should be
identified. Currently, knowledge on the mechanisms through which obesity
increases the risk of AF remain largely unclear and insufficient to develop
such strategies. Franciscus Gasthuis & Vlietland is one of the largest
bariatric surgery centers of The Netherlands, with multiple research projects
focusing on the obesity patient.
Study objective
To assess the prevalence of subclinical AF in obesity patients by using
different contemporary AF-detection applications (primary objective). To
investigate the potential role of GLS as a parameter to predict presence of AF
in obesity patients (primary objective).
To identify high-risk criteria for an obesity patient to have AF (secondary
objective). To gain insight in the pathophysiology of the relation between
obesity and AF (secondary objective).
Study design
The value of AF-screening using an AF-detection patch or an insertable loop
recorder (ILR) will be studied in an investigator driven, cross sectional,
observational cohort study of obesity patients (primary objective). Selected
patients are obesity patients who are screened for bariatric surgery, aged 50
years and older, without a history of cardiac disease. Patients will undergo
conventional and advanced echocardiography and laboratory tests as well to
investigate signs of subclinical cardiac dysfunction that may be related to AF
(secondary objective). Also, a prospective follow-up study of obesity patients
undergoing bariatric surgery will be performed to gain insight in the
pathophysiology of increased risk of AF in obesity (secondary objective).
Study burden and risks
For this study, patients will have to undergo some extra tests. However, the
echocardiogram and AF-detection patch are considered harmless and the blood
samples will be taken from a venapunction that will be performed anyway for
clinical reasons. The amount of blood taken for the extra blood samples (total
of 22 ml per visit) does not imply any risk for the patient. Only the subset of
patients that will receive an ILR has to make an extra visit to the hospital.
In a recent study it was shown that there were no major complications in
patients undergoing ILR implantation. As obesity is one of the most important
public health problems in the Western world and the prevalence of AF is
increasing, the risk to and burden for the subjects will be in proportion to
the potential value of the research.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
BMI of >= 35 kg/m2 and scheduled for bariatric surgery, age >= 50 years and
written informed consent.
Exclusion criteria
Known cardiac disease.
Design
Recruitment
Medical products/devices used
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 | NL73987.100.20 |
| Other | NL8635 |