Short summary

WECURE HFpEF is a prospective, multicenter Phase II clinical trial investigating whether weight loss through bariatric surgery can reverse obesity-related heart failure with preserved ejection fraction (HFpEF). The primary endpoint is change and/or normalization of pulmonary capillary wedge pressure (PCWP)/filling pressure in the heart during exercise. A total of 152 patients with HFpEF (BMI ≥35 kg/m²) will be followed for 12 months with invasive hemodynamic, metabolic, and functional assessment

Rationale

Heart failure with preserved ejection fraction (HFpEF) is increasingly driven by obesity, which causes cardiac stiffness, impaired relaxation, and elevated filling pressures. In obese HFpEF, left ventricular filling pressure during exercise is strongly linked to excess body mass, suggesting a reversible hemodynamic mechanism. Weight loss has shown favorable effects on cardiac structure, inflammation, and exercise capacity. However, it remains uncertain to what extent weight loss may reverse the pathophysiology of HFpEF. The aim of the WECURE HFpEF trial is to determine whether substantial weight loss achieved by bariatric surgery can normalize pulmonary capillary wedge pressure (PCWP) during exercise and thereby reverse the obese HFpEF phenotype.

Description of the cohort

The study will include 152 adult patients with symptomatic heart failure with preserved ejection fraction (HFpEF) and obesity (BMI ≥35 kg/m²) who meet national criteria for bariatric surgery. Participants will be recruited from the Departments of Endocrinology, including Steno Center and Cardiology at Odense and Aarhus University Hospitals. All participants will be evaluated as outpatients and undergo comprehensive cardiometabolic and invasive hemodynamic assessments before and after surgery.

Data and biological material

The study will collect comprehensive clinical, physiological, and biological data. Biological material will include blood and urine samples for metabolic, hormonal, and inflammatory analyses. Data categories will comprise demographic information, medical history, diagnoses, and detailed cardiometabolic profiles. Additional data will be obtained from patient journals. Participants will also complete validated questionnaires on symptoms and quality of life. Assessments include right heart catheterization at rest and during exercise, echocardiography, peak VO₂ bicycle testing, and CT scanning.

Collaborating researchers and departments

Department of Endocrinology, OUH. Steno Diabetes Center Odense, OUH.Department of Cardiology, Aarhus University Hospital. Department of Endocrinology, Esbjerg Hospital and Aarhus university. Department of Surgery, Esbjerg Hospital and Viborg Hospital.

• Mads Andersen, AU. Jens Bruun, AU. Claus Bogh Juhl, Esbjerg. Karen Floyd, Esbjerg. Tobias Stadil, Viborg. Jan Frystyk, OUH. Kurt Højlund, SDCO.

Region midtjylland, Region Southern Denmark