Prospective Analysis of Diastolic Stress Tests to Detect Exercise Induced Heart Failure With Preserved Ejection Fraction (HFpEF) in Patients With Intermediate Risk (DEST-HF Study, Diastolic Exercise Stress Testing in Heart Failure)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- PAWP increase across the four stress tests
研究概览
简要总结
Patients with an intermediate risk (HFA-PEFF score 2-4 points) for heart failure with preserved ejection fraction (HFpEF) will be further investigated with invasive right heart catheterization. All patients with a resting pulmonary artery wedge pressure (PAWP) <15mmHg will undergo the following stress test modalities in a randomized order: (1) bicycle ergometry, (2) dynamic handgrip exercise, (3) 500ml fluid challenge over 5 minutes, (4) leg raise testing. Exercise induced HFpEF will be diagnosed if PAWP rises to >25mmHg.
详细描述
Patients reporting to the investigators' clinic for in- and outpatient consultation and a HFA-PEFF score of 2-4 points will be recruited if their dyspnea is not sufficiently explained by other causes than HFpEF. Patients will undergo a baseline clinical exam, transthoracic echocardiography with measurement of diastolic parameters, and ECG. NYHA class will be reported, standard lab works (NTproBNP, GFR, CRP, Hb, PLT, blood gas analysis) will be taken. The number of patients with a PAWP increase in right heart catheterization (brachial access under sonographic guidance) from a resting value of <15mmHg to >25mmHg during stress testing will be assessed across the four interventions. During bicycle ergometry (semi-supine position) spiroergometric data and gas exchange variables (cardiopulmonary exercise testing) will be co-assessed. Between the testing modalities a 10-minute break will allow hemodynamic variables to normalize.
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
- •Age > 18 years
- •Unclear etiology of dyspnea with non-invasive testing
- •HFA-PEFF score 2-4 points and thus an intermediate risk for HFpEF
- •Willingness to participate and obtained written consent
排除标准
- •Consent for study participation not obtained
- •Age < 18 years
- •Medical contraindications to perform right heart catheterization
结局指标
主要结局
PAWP increase across the four stress tests
时间窗: 1 year
Number of patients with an increase of PAWP\<15mmHg at rest to \>25mmHg during stress testing.
次要结局
- Association of PAWP increase and changes of VO2peak during bicycle ergometry(1 year)
- Changes of pulmonary vascular resistance (PVR) across the four stress tests(1 year)
- Changes of mean pulmonary artery pressure (mPAP) across the four stress tests(1 year)
研究者
Peter Lüdike
Professor of Cardiology
University Hospital, Essen