Screening Adults With Obesity to Reduce Heart Failure Events

Condition(s) studied

Investigational drug(s) / intervention(s)

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'.

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with a combined endpoint of left ventricular dysfunction and/or heart failure — 1 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.

Trial sites (1)

More Franciscus Gasthuis trials in the Netherlands

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