Clinical trial

Screening Adults With Obesity to Reduce Heart Failure Events

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06137261

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Heart Failure

Full registry criteria

Inclusion Criteria: * Age ≥45 year * BMI ≥30 kg/m2 * Written informed consent. Exclusion Criteria: * Known cardiac disease (determined by asking the patient and by assessment of the available patient files). * Treatment with weight-reducing medication.

Treatments and study arms

Screening for heart failure

Diagnostic Test

• 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'.

Primary outcomes

Number of participants with a combined endpoint of left ventricular dysfunction and/or heart failure1 year

Asymptomatic left ventricular dysfunction (assessed with echocardiography) was chosen as a component of the primary endpoint as it reflects a heightened risk status, specifically to the later development of heart failure. Left ventricular dysfunction is defined as a left ventricular ejection fraction \<50%, a ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity greater than 15, or global longitudinal strain \<16%. Presence of heart failure will be defined as HF symptoms requiring emergency hospital admission.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Franciscus Gasthuis & Vlietland🇳🇱 Rotterdam, Netherlands

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