Adipose Tissue Inflammation in the Development, Maintenance and Functional Impairments in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adipose tissue inflammation
研究概览
简要总结
To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Epicardial, paracardial, paraaortic/paravascular, subcutaneous adipose tissue samples as well as myocardial tissue will be harvested during cardiac surgery. Inflammatory patterns of these tissues and their relation to circulating markers will be investigated.
详细描述
Heart Failure with preserved Ejection Fraction (HFpEF) is a growing public health concern with an increasing incidence, high morbidity and mortality and no proven therapy to date. Better characterization of individual pathophysiological implications is mandatory to develop effective therapeutic strategies or preventive programs. Obesity is an important risk factor for the development of HFpEF and also modulates its course possibly by its association with systemic inflammation. However, the role of adipose tissue (AT) inflammation in the development, maintenance and functional impairments in HFpEF has been under-investigated. Dysfunctional AT leads to a shift from a protective adipokine profile to an imbalanced production of pro-inflammatory, pro-oxidant and pro-fibrotic adipokines. Besides depot specific paracrine effects, the overall secretory activity or endocrine effect of AT can be evaluated in peripheral plasma.
The investigators hypothesize that adipose inflammation distinguishes obese HFpEF patients from obese patients without heart failure and that adipose tissue inflammation is a key driver the maintenance and development of HFpEF and determines functional capacity.
In addition the investigators hypothesize that the degree of myocardial inflammatory alterations is more closely related to epicardial tissue alterations than subcutaneous or visceral AT tissue inflammation or peripheral adipokine profiles.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HFpEF: Left ventricular ejection fraction ≥ 50%, NT-pro-BNP ≥ 125ng/l, evidence of structural heart diseases (diastolic dysfunction, left ventricular-hypertrophy or left atrial-dilatation), BMI ≥ 30kg/m²
- •Non-HF patients: No history of heart failure, Left ventricular ejection fraction > 50% and NT-pro-BNP <125ng/l
排除标准
- •Previous cardiac surgery / coronary intervention / myocardial infraction
- •Acute coronary syndrome (Serum levels of troponin T >50 pg/ml)
- •Left ventricular ejection fraction < 50%
- •Indication for concomitant valvular surgery
- •Planned beating heart coronary bypass surgery
- •Hemodynamic instability
- •Contraindication for magnetic resonance imaging
- •Pregnancy
- •Age < 18 years
- •No informed consent possible
结局指标
主要结局
Adipose tissue inflammation
时间窗: Tissue collection during surgery.
Adipose tissue inflammation and distribution as well as association with adipokines
次要结局
- Cardiac MRI - Epicardial fat(At baseline, before surgery.)
- Cardiac MRI - Myocardial function(At baseline, before surgery.)
- Echocardiography(At baseline, before surgery and at follow-up approximately three months after surgery.)
- Stress echocardiography(At follow-up approximately three months after surgery.)
- Evaluation of serum adipokine levels(At baseline, before surgery.)
- Functional capacity on spiroergometry(At follow-up approximately three months after surgery.)
研究者
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital