OBESE-HFpEF: Prevalence and Mediators of Heart Failure (Preserved Ejection Fraction) in the Dutch Obesity Clinic South - Towards Preventing Obesity Related HFpEF''
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at baseline.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Patients with obesity grade 2 or higher presenting at the Dutch obesity clinic requesting MBS.
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.
结局指标
主要结局
Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at baseline.
时间窗: 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.
次要结局
- 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)
- Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (IL6).(Baseline)
- Mean difference between HFpEF, pre-HFpEF and patients without HF concerning NT-proBNP(Baseline)
- Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (BMI).(Baseline)
- Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (Waist-to-Height ratio).(Baseline)
- Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipocyte cell size.(Baseline)
- Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipose tissue hyperplasia(Baseline)
- Delta in low grade inflammation (High sensitivity C-reactive protein) from baseline to 1- and 2 year follow-up.(2 years)
- Delta in low grade inflammation (IL-6) from baseline to 1- and 2 year follow-up(2 years)
- Delta in NTproBNP from baseline to 1- and 2 year follow-up.(2 years)
- Delta in functional capacity from baseline to 1- and 2 years folllow-up(2 Years)
- Change in antropomorphic measures (BMI) from baseline to 1- and 2 year follow-up(2 years)
- Change in antropomorphic measures (Waist-to-height ratio) from baseline to 1- and 2 year follow-up(2 years)