跳至主要内容
临床试验/NCT05481814
NCT05481814撤回不适用

The Role of Cardiopulmonary Stress Testing in Diagnostic Evaluation of Paradoxical Low Gradient Aortic Valve Stenosis

Henry Ford Health System1 个研究点 分布在 1 个国家开始时间: 2017年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Functional status

研究概览

简要总结

Severe aortic stenosis is a condition with poor life expectancy once it becomes symptomatic. There are no prospective studies illustrating the utility of cardiopulmonary stress (CPX) testing in diagnosing and prognosticating patients with paradoxically low gradient and low flow severe aortic stenosis. We aim to prospectively investigate the utility of CPX in this patient population with the hypothesis that utilizing CPX parameters would better identify higher risk patients warranting further evaluation and possibly intervention sooner.

详细描述

This will be a prospective crossectional, longitudinal study recruiting patients by invitation with paradoxical low flow low gradient severe aortic stenosis. Patients with PLFLG AS will have been identified in other studies and these patients will be approached for enrollment in the study. Patients deemed appropriate for enrollment will undergo recumbent bicycle stress testing with concomitant measure of gas exchange. The bicycle will be at 30 degrees with initiation of minimal resistance for 3 minutes, followed by an increase in work-rate of 25 watts every two minutes until the patient reaches a sign/symptom-limited maximum exertion or test limiting symptoms develop. Charts will be reviewed for baseline medical conditions and demographics. CPX protocol will be standard HFH protocol supervised by exercise physiologist. The first phase of the study will be investigating if these asymptomatic patients will be reclassified to symptomatic as defined by reduced V02 Max. The second phase will be following these patients for long term adverse events and if V02 max correlates with a higher risk.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Aortic valve area <1 cm2
  • Mean aortic pressure gradient <40 mmHg,
  • Left ventricular ejection fraction >50% by 2D transthoracic echocardiography

排除标准

  • Ischemic heart disease
  • Severe mitral valve disease (regurgitation or stenosis)
  • Moderate or severe aortic regurgitation
  • Pulmonary hypertension (PA pressure >50 mmHg)
  • Uncontrolled hypertension (Systolic BP or Diastolic BP greater than 150/90)
  • Inability or unwillingness to exercise.

结局指标

主要结局

Functional status

时间窗: August 30 2017-April 30 2017

Evaluate changes in rest vs. Peak V02 at maximal exercise capacity.

次要结局

  • Follow-up(August 30 2017- August 30 2019)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karthikeyan Ananthasubramaniam

Senior Staff Cardiologist

Henry Ford Health System

研究点 (1)

Loading locations...

相似试验