Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HFpEF-positive patients
研究概览
简要总结
Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools
详细描述
Multiple diagnostic tests, including stress tests and the invasive conduction of left ventricular pressure-volume loops via conductance catheter (as gold standard) will be performed in patients with unexplained dyspnea NYHA II-III in order to identify patients with a heart failure with preserved ejection fraction (HFpEF). The results will be compared to previously reported diagnostic scores such as the H2FPEF and the HFA-PEFF score.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyspnea NYHA II-III
- •age 18-90 years
- •left ventricular ejection fraction ≥ 50%
- •ability to give informed consent
排除标准
- •unstable cardiac disease with acute decompensation
- •documented former LVEF ≤ 40%
- •heart valve disease with medium or high grade insufficiency or stenosis
- •coronary heart disease with hemodynamically relevant coronary stenosis
- •specific cardiomyopathia
- •acute or chronic cardiac inflammation (myocarditis, pericarditis)
- •former heart transplantation
- •relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea
- •FEV1/VC < 70%
- •hemoglobin < 5 mmol/l
- •pregnant or nursing women
- •contraindication for one of the diagnostic tests
结局指标
主要结局
HFpEF-positive patients
时间窗: Within one day
Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction
次要结局
- H2FPEF score(Within two days)
- Difference in MRI parameters(Within two days)
- Difference in pulmonary artery pressure (right heart catheter)(Within two days)
- HFA-PEFF score(Within two days)
- Difference in DPVQ (echocardiographic) after one year(1 year)
- Difference in E/E' (echocardiographic) after one year(1 year)
- Difference in E/E' (echocardiographic)(Within two days)
- Difference in DPVQ (echocardiographic)(Within two days)
- Difference in GLS (echocardiographic)(Within two days)
- Difference in wedge pressure (right heart catheter)(Within two days)
- Difference in GLS (echocardiographic) after one year(1 year)
研究者
Rolf Wachter
Professor
University of Leipzig