Preventing obesity-related HFpEF
OBESE-HFpEF: Prevalence and Mediators of Heart Failure (Preserved Ejection Fraction) in the Dutch Obesity Clinic South - Towards Preventing Obesity Related HFpEF''
Zuyderland Medisch Centrum · NCT07539766
We will follow about 250 adults with obesity who are having metabolic bariatric surgery to see if weight loss prevents or reverses early HFpEF.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum (other) |
| Locations | 1 site (Heerlen, Limburg) |
| Trial ID | NCT07539766 on ClinicalTrials.gov |
What this trial studies
This observational longitudinal cohort will enroll about 250 adults with obesity who are eligible for metabolic bariatric surgery and perform extensive baseline phenotyping including echocardiography, blood tests, and adipose tissue sampling. Participants will receive standard multidisciplinary care with bariatric surgery and lifestyle support, and will return for repeated cardiac and functional assessments at 1 and 2 years. The study aims to determine how common HFpEF and pre-HFpEF are in patients seeking surgery and to track changes in cardiac function, biomarkers, quality of life, and 6-minute walk distance after weight loss. Data will be used to examine reclassification between HFpEF categories and identify pathophysiologic mediators linked to improvement or persistence of disease.
Who should consider this trial
Good fit: Adults aged 35 or older with obesity (BMI ≥40 kg/m2 or BMI ≥35 kg/m2 with an obesity-related comorbidity) who are eligible for metabolic bariatric surgery, can undergo the study tests, and are proficient in Dutch.
Not a fit: Patients with a history of reduced LVEF, severe valvular or congenital heart disease, prior bariatric surgery, BMI >60 kg/m2, inability to safely undergo surgery or study tests, or who cannot give informed consent or speak Dutch are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the findings could show that substantial weight loss after bariatric surgery prevents or reverses early HFpEF, improving symptoms and long-term outcomes.
How similar studies have performed: Previous observational studies and surgical cohorts have reported cardiac and symptomatic improvements after bariatric surgery, but prospective data specifically documenting reversal or reclassification of HFpEF are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 35 years * Eligible for surgical treatment for obesity, according to the Dutch guideline, i.e. a BMI ≥ 40 kg/m2 or a BMI ≥ 35 kg/m2 with one or more comorbidities associated with obesity. (23) Exclusion Criteria: * Inability to provide informed consent. * A BMI \>60 kg/m2 * Inability of undergoing metabolic bariatric surgery safely. * Inability to undergo the study measurement/tests. * Not proficient in the Dutch language * A medical history of a reduced LVEF at any time, history of severe cardiac valve defects or severe congenital cardiac defects. * A medical history of previous metabolic bariatric surgery.
Where this trial is running
Heerlen, Limburg
- Zuyderland Medisch Centrum Heerlen — Heerlen, Limburg, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Sandra van Wijk, Dr. — Zuyderland Medical Center
- Study coordinator: Lukas Peeters, Master of Science in Medicine
- Email: luka.peeters@zuyderland.nl
- Phone: +32479092470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure and Preserved Ejection Fraction, Obesity, Heart Failure, Heart Failure with preserved ejection fraction, Metabolic Bariatric Surgery, Prospective