To investigate whether active screening for early signs of HF and its risk factors in adults with obesity without known heart disease improves clinical outcome.
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is a combined endpoint of left ventricular dysfunction
and/or HF admission.
Secondary outcome
- Prevalence at baseline of not yet diagnosed HF as identified by active
screening
- Prevalence at baseline of undiscovered risk factors for HF (e.g.
hypertension, diabetes) as identified by active screening
- Risk factors for having HF in subjects with a HF diagnosis at baseline by
active screening (e.g. age, sex, BMI, waist circumference, hypertension,
diabetes)
- Quality of life (EQ-5D-5L questionnaire) at 1 year follow-up in all subjects
- Effect of HF treatment on dyspnea (NYHA classification) at 1 year follow-up
in screened patients with HF at the time of screening
Background summary
Obesity prevalence in Dutch adults increased to 14.2% in 2020. Obesity is
strongly associated with cardiovascular disease, especially heart failure (HF).
HF is a serious condition with significant morbidity and mortality. HF in
people with obesity often remains undetected for a relatively long time,
because symptoms are attributed to the obesity and not to possible HF. As a
result, individuals seek help late for already advanced HF. Screening may
reveal HF risk factors or a HF diagnosis. Early treatment initiation will
improve prognosis, both in terms of quality of life and morbidity and
mortality.
Study objective
To investigate whether active screening for early signs of HF and its risk
factors in adults with obesity without known heart disease improves clinical
outcome.
Study design
Investigator driven, not blinded, randomized controlled superiority trial.
Intervention
Participants will be randomized to either an active screening on HF and its
risk factors (the intervention group) or standard care. The intervention group
will be screened using anamnesis, physical examination, an electrocardiogram,
blood tests and an echocardiogram. In a subset of patients in the intervention
group, screening will reveal HF or additional HF risk factors, such as
hypertension or diabetes, that will be treated and followed according to
guidelines. Participants randomized to standard care will not undergo any tests
at baseline.
Study burden and risks
The burden for participants is relatively low. Nevertheless, participants in
the intervention group do have to undergo some extra tests at baseline and
follow-up, and participants in the usual care group at follow-up. However, the
diagnostic procedures of the study protocol are widely accepted and well-known
to be free of any risk of serious adverse events. As obesity is one of the most
important public health problems in the Western world and the prevalence of HF
is increasing, the risk to and burden for the participants 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
Age >=45 year, BMI >=30 kg/m2, and written informed consent.
Exclusion criteria
Known cardiac disease (determined by assessment of the available patient files
and by asking the patient).
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 | NL84213.100.23 |