Screening Adults With Obesity to Reduce Heart Failure Events

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.

NCT Number	NCT06137261
Lead Sponsor	Franciscus Gasthuis Collaborators: Erasmus Medical Center, Star-shl, De Leefstijlkliniek, Leefstijl Centrum Rotterdam, Voedingsadvies Broer, Biotronik SE & Co. KG, Boehringer Ingelheim, Sanofi, Novo Nordisk A/S
Conditions	Obesity, Heart Failure
Enrollment	420 participants
Start Date	2024-02-26
Primary Completion	2026-07-08 (estimated)
Study Completion	2026-07-08 (estimated)
Updated on ClinicalTrials.gov	2025-08-21