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Screening Adults With Obesity to Reduce Heart Failure Events
Sponsor: Franciscus Gasthuis
Summary
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.
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2024-02-26
Completion Date
2026-07-08
Last Updated
2025-08-21
Healthy Volunteers
No
Conditions
Interventions
Screening for heart failure
• Anamnesis and Physical examination: Focus on signs of HF; will be performed by a trained employee. • ECG: A standard 12-lead ECG will be recorded by a trained employee and will be interpreted by an experienced cardiologist. • Echocardiography: A standard full echocardiogram will be acquired by a trained employee. • Blood biomarkers: Venous blood samples will be taken and circulating levels of a broad range of markers related to obesity and/or heart failure will be determined. Also, an extra 10 mL blood sample will be drawn during the same venepuncture to be stored to determine additional biomarkers at a later stage. • EQ-5D-5L questionnaire: EQ-5D-5L comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are divided into five degrees of severity, ranging from 'no problems' to 'extreme problems'.
Locations (1)
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands