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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Franciscus Gasthuis & Vlietland
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.