NCT06137261Active, not recruiting
Screening Adults With Obesity to Reduce Heart Failure Events
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
Rationale: 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. 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. Study population: Consecutive individuals with obesity (body mass index ≥30 kg/m2) ≥ 45 years, without known cardiac disease, who sign up to participate in a Combined Lifestyle Intervention program, will be recruited. Intervention: Participant randomized to the intervention will undergo an active screening on HF and its risk factors, using anamnesis, physical examination, an electrocardiogram, blood tests and an echocardiogram. Main study parameters/endpoints: The main study endpoint is a combined endpoint of left ventricular dysfunction and/or HF.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 14 Jun 2023
- Start date
- 26 Feb 2024
- Primary completion date
- 8 Dec 2026
- Lead sponsor
- Franciscus Gasthuis
- Diseases
- Heart failure, Obesity
- NCT number
- NCT06137261
What you commit to
- Study type: Interventional
- Planned participants: 420
- From 26 Feb 2024 to the primary completion date, 8 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with weight-reducing medication.
Other illness
- Known cardiac disease (determined by asking the patient and by assessment of the available patient files).
Who the study is looking for
- Age ≥45 year
- BMI ≥30 kg/m2
- Written informed consent.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Franciscus Gasthuis & Vlietland Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.