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临床试验/NCT03565471
NCT03565471已完成不适用

Atrial Septal Defect - Exercise Capacity and Pulmonary Hypertension

University of Aarhus1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Peak oxygen uptake (ml O2/kg/min)

研究概览

简要总结

The purpose of the study is to compare exercise capacity, cardiac contractility, pulmonary vascular pressures and heart rate variability between patients with an atrial septal defect and healthy controls.

详细描述

  1. Background Patients born with atrial septal defect (ASD) in the heart, have long been assumed healthy after closure of their defect. However, recent studies show, that despite closure of the ASD the risks of arrhythmia, stroke and pneumonia are increased. It is also shown that ASD patients die earlier than the background population and the cause of death is most often cardiac. The reason for this higher mortality and morbidity is unknown and the scope of this thesis.
  2. Aim To determine if closed (both surgical and transcatheter) ASD patients have reduced exercise capacity, impaired right and left ventricular function, increased pressure in the pulmonary system, and reduced heart rate variability when compared with healthy controls. The investigators will also examine if method of closure is of importance.
  3. Hypothesis

Primary endpoint:

The shunting effect alters the hemodynamic in the ASD heart resulting in lower cardiopulmonary exercise capacity when compared with healthy controls.

Secondary endpoints:

The shunting effect alters the hemodynamic in the ASD heart when compared with healthy controls resulting in

  • Impaired force frequency relationship with a reduction in contractility at optimal heart rate.
  • Increased pulmonary arterial pressure.
  • Twice as many ASD patients with decreased heart rate variability.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • 18 years and above.
  • Informed consent to participate.
  • Patients: Diagnosed with an atrial septal defect. More than 3 years have passed since closure of the atrial septal defect.
  • Controls: No history of heart or lung disease.

排除标准

  • Lung disease.
  • Ischemic heart disease.
  • Diabetes.
  • Hypertension.
  • Valve pathology.
  • Patients: Concomitant heart disease
  • Controls: Usage of prescription drugs interfering with the cardiopulmonary function.

结局指标

主要结局

Peak oxygen uptake (ml O2/kg/min)

时间窗: 8-12 minutes

using exercise testing

Peak exercise minute ventilation (ml/min)

时间窗: 8-12 minutes

using exercise testing

Peak heart rate (beats/min)

时间窗: 8-12 minutes

using exercise testing

Maximal workload (W/kg)

时间窗: 8-12 minutes

using exercise testing

次要结局

  • Tricuspid annular peak systolic velocity (mm)(8-12 minutes)
  • Return gradient at the tricuspid valve (mmHg)(8-12 minutes)
  • Mixed venous oxygen saturation (%)(8-12 minutes)
  • Heart rate variability(48 hours)
  • Cardiac output (L/min)(8-12 minutes)
  • Central venous pressure (mmHg)(8-12 minutes)
  • Pulmonary artery wedge pressure (mmHg)(8-12 minutes)
  • Cardiac index (L/min)(8-12 minutes)
  • Pulmonary artery pressure (mmHg)(8-12 minutes)
  • Heart rate, minimum, maximum and mean (beats/min)(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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