Heart Failure and Preserved Ejection FractionObesity (Disorder)Heart Failure
Study 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
Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at baseline. — Baseline The primary endpoint of this study is the total percentage of individuals with obesity who have (pre-)HFpEF within our study population. This will be measured by performing echocardiography, physical examination, and measuring natriuretic peptides. For the definition of HFpEF, we use the diagnostic criteria from the European HF guidelines. (12)
1. HFpEF is defined as follows :
* symptoms and signs of HF (table II, at least 1 typical/more specific or 2 less typical/less specific)
* evidence of structural and/or functional cardiac abnormalities demonstrated by echocardiography (table III) and/or raised natriuretic peptides (NPs)
* LVEF ≥50%
2. Pre-HFpEF:
* No symptoms or signs of HF (table II).
* Evidence of structural and/or functional cardiac abnormalities demonstrated by echocardiography (table III) and/or raised natriuretic peptides (NPs)
* LVEF ≥50%,
3. Individuals with obesity who do not meet the criteria above are consequently the patients that are not as having (pre-)HFpEF.
Trial sites (1)
Facility
City
Region
Status
Zuyderland Medisch Centrum Heerlen
Heerlen
Limburg
Recruiting
More Zuyderland Medisch Centrum trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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