Heart Failure, Heart Failure and Preserved Ejection Fraction, Obesity (Disorder)
Conditions
Keywords
Obesity, Heart Failure with preserved ejection fraction, Metabolic Bariatric Surgery, Prospective
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.
Detailed description
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.
Interventions
None listed
Sponsors
Zuyderland Medisch Centrum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delta in total percentage of (pre-)HFpEF cases after metabolic bariatric surgery at 1-and 2 years follow-up. | 2 years | — |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (High sensitivity C-reactive protein). | Baseline | Difference in High sensitivity C-reactive protein (mg/L) at baseline |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (IL6). | Baseline | Difference in interleukin-6 (pg/ml) at baseline |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning NT-proBNP | Baseline | Difference in NT-proBNP (ng/L) at baseline. |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (BMI). | Baseline | Difference in BMI (Kg2/m) at baseline. |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (Waist-to-Height ratio). | Baseline | Difference in Waist-to-Height ratio (Waist circumference (cm) divided by height (cm)) at baseline. |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipocyte cell size. | Baseline | Difference in adipocyte cell size in diameter (micrometers) and cross sectional area (square micrometers) at baseline. |
| Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipose tissue hyperplasia | Baseline | Difference in adipose tissue hyperplasia in total cell number and adipcyte cell density (cells/mm2) at baseline. |
| Delta in low grade inflammation (High sensitivity C-reactive protein) from baseline to 1- and 2 year follow-up. | 2 years | Changes in High sensitivity C-reactive protein (mg/L), from baseline to 1- and 2 years after metabolic bariatric surgery. |
| Delta in low grade inflammation (IL-6) from baseline to 1- and 2 year follow-up | 2 years | Changes in IL-6 from baseline (pg/ml), from baseline to 1- and 2 years after metabolic bariatric surgery. |
| Delta in NTproBNP from baseline to 1- and 2 year follow-up. | 2 years | Changes in N-terminal brain natriuretic peptide (ng/L), from baseline to 1- and 2 years after metabolic bariatric surgery. |
| Delta in functional capacity from baseline to 1- and 2 years folllow-up | 2 Years | Change in the six-minute walking test distance from baseline to 1- and 2 years follow-u after metabolic bariatric surgery. |
| Change in antropomorphic measures (BMI) from baseline to 1- and 2 year follow-up | 2 years | Changes in BMI (Kg2/m), from baselin to 1- and 2 years after metabolic bariatric surgery. |
| Change in antropomorphic measures (Waist-to-height ratio) from baseline to 1- and 2 year follow-up | 2 years | Changes in Waist-to-height ratio (Waist circumference (cm) divided by height (cm)), from baseline to 1-and 2 years after metabolic surgery. |
Countries
Netherlands
Contacts
CONTACTLukas Peeters, Master of Science in Medicine
PRINCIPAL_INVESTIGATORSandra van Wijk, Dr.
Zuyderland Medical Center
Outcome results
None listed