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临床试验/NCT00504647
NCT00504647Unknown1 期

Diastolic Ventricular Interaction and the Effects Of Biventricular Pacing in Hypertrophic Cardiomyopathy

University Hospital Birmingham6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年6月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
6
主要终点
Peak Exercise Oxygen Consumption.

研究概览

简要总结

Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in some cases be severe. This appears in most cases to be due to an impairment of the filling of the heart, especially on exercise this limits the amount of blood the heart is able to pump. Several factors may contribute to this slow filling of the heart, including (1) The heart contracts and relaxes in an incoordinate way (called 'dyssynchrony') which is inefficient, and (2) The filling of the main pumping chamber (the left ventricle) may be impeded by high pressure in the other ventricle(the right ventricle)- in other words the left ventricle is 'squashed' by the right ventricle. This is known as diastolic ventricular interaction.

Although drugs can improve the filling of the heart and relieve symptoms, some patients remain very symptomatic despite these drugs.

The mechanisms responsible for the filling abnormality in patients with Hypertrophic Cardiomyopathy are similar to those seen in the much more common condition known as Heart Failure. A special type of pacemaker technique called 'Biventricular Pacing' has been shown to markedly improve symtoms in patients with heart failure. This form of pacing has been shown to improve both 'dyssynchrony' ( incoordination) and 'ventricular interaction' (squashed left heart) in patients with Heart Failure.

We propose that Biventricular pacing may similarly improve these abnormalities in patients with Hypertrophic Cardiomyopathy, resulting in an improvement of symptoms. The study will focus on patients with the condition who have severe symtoms despite being on optimal currently available drug therapy.

详细描述

SUBJECTS Forty Participants, who fufil the entry criteria, will be selected. These Participants will be recruited from Cardiomyopathy clinics run at two sites. These are the Cardiomyopathy Clinics at the Heart Hospital, University College London, and from the Queen Elizabeth Hospital, Birmingham.

CONSENT Written informed consent will be obtained from all participants.

CLINICAL ASSESSMENT

A History will be taken and a Clinical Examination will be carried out. A validated Quality of life questionaire will be completed ( Minnesota Living with Heart Failure).

Maximal Cardiopulmonary exercise testing will be performed on a treadmill, with breath by breath respiratory gas sampling, using a face mask.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Hypertrophic Cardiomyopathy
  • Ability to perform peak exercise oxygen consumption test.

排除标准

  • Left ventricular outflow tract gradient more than 30mmHg
  • Peak Oxygen consumption more than 75% of maximum predicted.

结局指标

主要结局

Peak Exercise Oxygen Consumption.

时间窗: 4 month

次要结局

  • Myocardial Asynchrony Index(4 months)
  • Minnesota Quality of Life Questionnaire(4 months)

研究者

发起方
University Hospital Birmingham
申办方类型
Other

研究点 (6)

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