Screening Adults With Obesity to Reduce Heart Failure Events

NCT06137261 | Active Not Recruiting

• 1 other identifier: FR2023CAR01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Heart Failure

Keywords

Screening

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Secondary Outcomes (5)

• Prevalence of HF as identified by active screening

  Baseline

• Prevalence of undiscovered risk factors for HF as identified by active screening

  Baseline

• EQ-5D-5L questionaire

  1 year

• Self-rated health on a Visual Analogue Scale (EQ VAS)

  1 year

• Effect of HF treatment on symptoms in screened patients with HF at the time of screening

  1 year

Study Arms (2)

Participants randomized to HF screening

EXPERIMENTAL

Active screening on HF and its risk factors, using anamnesis, physical examination, an ECG, blood tests and an echocardiogram. After 1 year follow-up, both participants randomized to standard care and to screening for HF will be approached. Participants will be asked whether they have had an unplanned hospital admission for HF. Also, in all participants an echocardiogram will be acquired. Finally, participants will be asked to fill-out the HR-QoL with the EQ-5D-5L questionnaire.

Diagnostic Test: Screening for heart failure

Participants randomized to standard care

NO INTERVENTION

Participants randomized to standard care will not undergo any tests related to the study at baseline. After 1 year follow-up, both participants randomized to standard care and to screening for HF will be approached. Participants will be asked whether they have had an unplanned hospital admission for HF. Also, in all participants an echocardiogram will be acquired. Finally, participants will be asked to fill-out the HR-QoL with the EQ-5D-5L questionnaire.

Interventions

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'.

Participants randomized to HF screening

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥45 year
• BMI ≥30 kg/m2
• Written informed consent.

You may not qualify if:

• Known cardiac disease (determined by asking the patient and by assessment of the available patient files).
• Treatment with weight-reducing medication.

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Erasmus Medical Center: collaborator
• Star-shl: collaborator
• De Leefstijlkliniek: collaborator
• Leefstijl Centrum Rotterdam: collaborator
• Voedingsadvies Broer: collaborator
• Biotronik SE & Co. KG: collaborator
• Boehringer Ingelheim: collaborator
• Sanofi: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Franciscus Gasthuis & Vlietland

Rotterdam, 3045 PM, Netherlands

Location

MeSH Terms

Conditions

Obesity; Heart Failure

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Bas M van Dalen, Dr.

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: November 18, 2023
• Study Start: February 26, 2024
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)