OBESE-HFpEF: Towards Preventing Obesity Related HFpEF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35+
SponsorZuyderland Medisch Centrum
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Inability to provide informed consent.
A BMI >60 kg/m2
Inability of undergoing metabolic bariatric surgery safely.
Inability to undergo the study measurement/tests.
Trial population
Our study population consists of patients presenting at the DOC South requesting metabolic bariatric surgery. Our predetermined sample size was set at 250 participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Patients with obesity grade 2 or higher presenting at the Dutch obesity clinic requesting MBS.
Trial outcomes
Primary outcomes
1
Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at 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.
Time frame
BaselineSecondary outcomes
1
Delta in total percentage of (pre-)HFpEF cases after metabolic bariatric surgery at 1-and 2 years follow-up.
Time frame
2 years2
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (High sensitivity C-reactive protein).
Difference in High sensitivity C-reactive protein (mg/L) at baseline
Time frame
Baseline3
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (IL6).
Difference in interleukin-6 (pg/ml) at baseline
Time frame
Baseline4
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning NT-proBNP
Difference in NT-proBNP (ng/L) at baseline.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov