Screening Adults With Obesity to Reduce Heart Failure Events

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

Interventions

DIAGNOSTIC_TEST

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'.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Star-shl

  collaborator UNKNOWN

• De Leefstijlkliniek

  collaborator UNKNOWN

• Leefstijl Centrum Rotterdam

  collaborator UNKNOWN

• Voedingsadvies Broer

  collaborator UNKNOWN

• Biotronik SE & Co. KG

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• Sanofi

  collaborator INDUSTRY

• Novo Nordisk A/S

  collaborator INDUSTRY

• Franciscus Gasthuis

  lead OTHER

Principal Investigators

• Bas M van Dalen, Dr. · Franciscus Gasthuis & Vlietland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-26

Primary Completion

2026-07-08

Completion

2026-07-08

Countries

• Netherlands

Study Locations