Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Composite endpoint cardiovascular events
研究概览
简要总结
Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •One or more of the following criteria:
- •Age > 60 years
- •Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs)
- •Diabetes mellitus Type I or II
- •Atrial fibrillation
- •Chronic kidney disease (GFR < 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g)
- •BMI ≥ 30 kg/m2
- •NYHA ≥ II
- •E/e' > 8
排除标准
- •Left ventricular ejection fraction < 50 %
- •Significant valve disease (Grade III or higher)
- •History of interventional or surgical valve repair
- •Regional wall motion abnormalities
- •Respiratory diseases as a known cause for dyspnea
- •Atrial flutter or fibrillation during examination
- •Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy
- •History of heart transplantation
结局指标
主要结局
Composite endpoint cardiovascular events
时间窗: 24 months
Cardiovascular hospitalisation or death
Change in HFA-PEFF-Score
时间窗: 24 months
Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF \[min. 0 points, max. 6 points\]
Development of HFpEF
时间窗: 24 months
Defined as ≥ 5 points in HFA-PEFF-Score Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF \[min. 0 points, max. 6 points\]
次要结局
- Development or aggravation of albuminuria(24 months)
- Change of blood-creatinine(24 months)
- Change of NT-proBNP(24 months)
- Change of individual parameters included in the HFA-PEFF-Score(24 months)
- Change of NYHA-class(24 months)
研究者
Alexander Schulz
Principal Investigator
University Medical Center Goettingen