NCT07539766 OBESE-HFpEF: Towards Preventing Obesity Related HFpEF
| NCT ID | NCT07539766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zuyderland Medisch Centrum |
| Condition | Heart Failure and Preserved Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-01-01 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Obesity, severe overweight, is a growing problem worldwide and increases the risk of heart failure, especially a type called heart failure with preserved ejection fraction (HFpEF). In HFpEF, the heart becomes stiffer. This makes it harder for the heart to fill with blood, which can lead to shortness of breath during physical activity. In the Netherlands, 15% of the population has obesity. In South Limburg, this is even higher at 19%. Among people with HFpEF, obesity is much more common: about 50% of these patients have obesity. Life expectancy in people with HFpEF is poor, and current treatment mainly focuses on reducing symptoms. Early recognition and treatment of risk factors, such as obesity, are therefore very important. This study includes about 250 people with obesity. Using a heart ultrasound and tests of blood and fat tissue, we will look for early signs of HFpEF and study the effects of weight loss. The measurements will be repeated after 1 and 2 years. The goal of this study is to better understand how obesity contributes to HFpEF and how weight loss affects the heart. This research may help improve future treatments for patients with HFpEF.
Eligibility 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.
Contact & Investigator
Sandra van Wijk, Dr.
PRINCIPAL INVESTIGATOR
Zuyderland Medical Center
Frequently Asked Questions
Who can join the NCT07539766 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Heart Failure and Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07539766 currently recruiting?
Yes, NCT07539766 is actively recruiting participants. Contact the research team at luka.peeters@zuyderland.nl for enrollment information.
Where is the NCT07539766 trial being conducted?
This trial is being conducted at Heerlen, Netherlands.
Who is sponsoring the NCT07539766 clinical trial?
NCT07539766 is sponsored by Zuyderland Medisch Centrum. The principal investigator is Sandra van Wijk, Dr. at Zuyderland Medical Center. The trial plans to enroll 250 participants.
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