Clinical trial Recruiting at 1 site Observational Ages 35 and up

Preventing obesity-related HFpEF

Official title: OBESE-HFpEF: Prevalence and Mediators of Heart Failure (Preserved Ejection Fraction) in the Dutch Obesity Clinic South - Towards Preventing Obesity Related HFpEF''

Run by Zuyderland Medisch Centrum · NCT07539766 · Data updated 2026-11-12

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 typeObservational
Ages35 Years and up
SexAll
Enrollment250 (estimated)
SponsorZuyderland Medisch Centrum
Academic / other
Locations1 site (Heerlen, Limburg)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedMay 1, 2028
Study endsJanuary 1, 2029
Registry record updatedApril 20, 2026
Trial IDNCT07539766 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.