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临床试验/NCT04066777
NCT04066777已完成不适用

The Effect of Alcohol Septal Ablation Therapy on Left Ventricular Function and Invasive Hemodynamics at Rest and During Exercise in Patients With Hypertrophic Obstructive Cardiomyopathy

Steen Hvitfeldt Poulsen2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Pulmonary capillary wedge pressure (PCWP) during exercise

研究概览

简要总结

To examine patients with hypertrophic obstructive cardiomyopathy (HOCM) before and after septal alcohol ablation, to investigate the effect of the treatment in regards to changes in myocardial function, perfusion, invasive hemodynamics and exercise tolerance.

详细描述

Patients with HOCM who develop symptoms of heart failure are treated initially with non-vasodilating ß-blockers or verapamil to decrease myocardial contractility and heart rate. A substantial part of patients remain symptomatic despite medical treatment. In these patients interventional or surgical treatments (septal reduction therapies (SRT)) to reduce left ventricular outflow tract obstruction (LVOTO) is considered in the presence of moderate to-severe symptoms (New York Heart Association - functional class (NYHA) III-IV) and/or recurrent exertional syncope and an LVOTO gradient ≥50 mm Hg. In some centers, invasive therapy is also considered in patients with mild symptoms (NYHA Class II) who have a resting or maximum provoked gradient of ≥50 mm Hg (with exercise or Valsalva's maneuver) and moderate-to-severe mitral valve regurgitation. Advanced treatment options are alcohol septal ablation (ASA) or surgical myectomy often combined with mitral valve reconstructive surgery. These treatments have similar outcomes in terms of gradient reduction, symptom improvement and exercise capacity

No previous trials have examined the effect of ASA in HOCM with respect to changes in central hemodynamics and myocardial performance during exercise.

24 HOCM patients will be examined prior to ASA, and approximately six-nine months after ASA.

The examination set-up consists of simultaneous 1) transthoracic echocardiography (TTE), 2) right heart catheterization (RHC) and 3) cardiopulmonary exercise test (CPX).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Left ventricular wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by loading conditions
  • LVOT gradients ≥ 30 mmHg at rest and/or ≥ 50 mmHg at Valsalva's maneuver or exercise
  • NYHA ≥ III

排除标准

  • < 18 years
  • Fertile women who do not use anti-contraceptives
  • Pregnancy
  • Patients are allowed to have a pacemaker (eg. an implantable cardioverter defibrillator (ICD)) but cannot be pace-dependent
  • Amiodarone treatment
  • Persistent or permanent atrial fibrillation/flutter
  • Previous SRT
  • Alcohol or drug abuse
  • Significant co-morbidity (judged by the investigator)
  • Patients who cannot give valid consent (e.g. mental illness or dementia) or who do not understand Danish.

结局指标

主要结局

Pulmonary capillary wedge pressure (PCWP) during exercise

时间窗: Changes will be evaluated after an expected average of 6-9 months after treatment

Change in PCWP at 75 watt (or maximum exercise, if this is \< 75 W)

次要结局

  • Change in GLS (%) at peak exercise(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • Pulmonary capillary wedge pressure (PCWP) at rest(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • LVOT gradient during maximum exercise(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • Changes of symptoms and quality of life estimated by KCCQ(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • Peak oxygen uptake (VO2-max)(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • Changes in biomarkers(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • Coronary flow reserve(Changes will be evaluated after an expected average of 6-9 months after treatment)
  • Work capacity(Changes will be evaluated after an expected average of 6-9 months after treatment)

研究者

发起方
Steen Hvitfeldt Poulsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Steen Hvitfeldt Poulsen

professor

Aarhus University Hospital Skejby

研究点 (2)

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