跳至主要内容
临床试验/NCT05055180
NCT05055180Unknown不适用

Afterload Dependence of Right Ventricular Myocardial Remodeling and Intrinsic Right Ventricular Myocardial Function in Heart Failure With Preserved Ejection Fraction

Heart Center Leipzig - University Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Phosphorylation of structural myocardial proteins

研究概览

简要总结

In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. In the present study alterations of intrinsic RV (systolic and diastolic) function, as assessed by invasive pressure volume loops, are examined in relation to tissue alterations on myocardial level and to the degree of RV afterload (pulmonary hypertension). Study aim is to gain insights into mechanisms contributing to the development of RV dysfunction and potentially identify new therapeutic targets.

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

入选标准

  • Clinical signs of heart failure
  • Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%)
  • Structural Heart Diseases on echocardiogram/ N terminal-pro-brain natriuretic peptide > 125ng/l
  • Elevated LV end-diastolic pressure at rest (>15mmHg) or during exertion (>=25mmHg)
  • No Heart Failure
  • Inclusion Criteria:
  • No signs of heart failure
  • Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%)
  • Normal LV end-diastolic pressure at rest (=<15mmHg) and during exertion (<25mmHg)

排除标准

  • Significant coronary artery stenosis at time of catheterization
  • Acute coronary syndrome or cerebral insult within 1 month of examination
  • more than moderate valvular diseases
  • pregnancy
  • contraindication to cardiac magnetic resonance imaging

结局指标

主要结局

Phosphorylation of structural myocardial proteins

时间窗: Baseline

Assessed on myocardial biopsy specimen

Right ventricular systolic and diastolic function

时间窗: Baseline

Assessed with pressure volume loops analysis

Biventricular myocardial fibrosis

时间窗: Baseline

Assessed with histopathology

次要结局

  • Functional capacity(Baseline)
  • Myocardial fibrosis on cardiac magnetic resonance(Baseline)

研究者

发起方
Heart Center Leipzig - University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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