An observational study in Heart Failure and Preserved Ejection Fraction, Obesity (Disorder) and Heart Failure, sponsored by Zuyderland Medisch Centrum. Recruiting at 1 site in Netherlands. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Zuyderland Medisch Centrum · Observational
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.
The study is an observational, longitudinal cohort study, with extensive phenotyping at baseline and at 1- and 2 years follow-up after Metabolic bariatric surgery. The baseline assessment corresponds to the intake phase at the obesity clinic. All patients will undergo Metabolic Bariatric Surgery and multi-disciplinary treatment focused on life style change. All patients will then be followed longitudinally with repeated assessments after 1- and 2 years follow-up.
The primary objective of this study is:
I) To determine the prevalence of HFpEF and (pre)-HFpEF in patients with obesity requesting MBS.
Secondary objective(s):
I) Evaluate the differences between the three study groups (HFpEF vs preHFpEF vs patients without HF) concerning pathophysiologic mediators, functional status, QoL and medical history/demographics at baseline.
II) Evaluate the prevalence of (pre-)HFpEF at 1- and 2 years after MBS, i.e. evaluating the reclassification (transition) in disease groups from baseline.
III) Evaluate changes in cardiac function and pathophysiologic mediators from baseline to 1- and 2 years after MBS.
IV) Evaluate changes in quality of life (QoL) and functional capacity measured as change in 6-minute walking test distance from baseline to 1- and 2 years after MBS.
199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.
This study's planned enrollment of 250 is above the median of 200 across 55 observational studies indexed under Heart Failure, Diastolic.
Browse Heart Failure, Diastolic studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Our study population consists of patients presenting at the DOC South requesting metabolic bariatric surgery. Our predetermined sample size was set at 250 participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Our study population consists of patients presenting at the DOC South requesting Metabolic bariatric surgery (MBS). 10-15 new patients present themselves weekly at the DOC South, from which study participants can be recruited. Our population is 35 years or older and has no previous history of a reduced ejection fraction, severe cardiac valve defects of severe congenital cardiac defects. Our population does not have a previous history of metabolic bariatric surgery.
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: Baseline
Delta in total percentage of (pre-)HFpEF cases after metabolic bariatric surgery at 1-and 2 years follow-up.
Time frame: 2 years
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: Baseline
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: Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning NT-proBNP
Difference in NT-proBNP (ng/L) at baseline.
Time frame: Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (BMI).
Difference in BMI (Kg2/m) at baseline.
Time frame: Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (Waist-to-Height ratio).
Difference in Waist-to-Height ratio (Waist circumference (cm) divided by height (cm)) at baseline.
Time frame: Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipocyte cell size.
Difference in adipocyte cell size in diameter (micrometers) and cross sectional area (square micrometers) at baseline.
Time frame: Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipose tissue hyperplasia
Difference in adipose tissue hyperplasia in total cell number and adipcyte cell density (cells/mm2) at baseline.
Time frame: Baseline
Delta in low grade inflammation (High sensitivity C-reactive protein) from baseline to 1- and 2 year follow-up.
Changes in High sensitivity C-reactive protein (mg/L), from baseline to 1- and 2 years after metabolic bariatric surgery.
Time frame: 2 years
Delta in low grade inflammation (IL-6) from baseline to 1- and 2 year follow-up
Changes in IL-6 from baseline (pg/ml), from baseline to 1- and 2 years after metabolic bariatric surgery.
Time frame: 2 years
Delta in NTproBNP from baseline to 1- and 2 year follow-up.
Changes in N-terminal brain natriuretic peptide (ng/L), from baseline to 1- and 2 years after metabolic bariatric surgery.
Time frame: 2 years
Delta in functional capacity from baseline to 1- and 2 years folllow-up
Change in the six-minute walking test distance from baseline to 1- and 2 years follow-u after metabolic bariatric surgery.
Time frame: 2 Years
Change in antropomorphic measures (BMI) from baseline to 1- and 2 year follow-up
Changes in BMI (Kg2/m), from baselin to 1- and 2 years after metabolic bariatric surgery.
Time frame: 2 years
Change in antropomorphic measures (Waist-to-height ratio) from baseline to 1- and 2 year follow-up
Changes in Waist-to-height ratio (Waist circumference (cm) divided by height (cm)), from baseline to 1-and 2 years after metabolic surgery.
Time frame: 2 years
Plan to share: Undecided
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