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临床试验/NCT00976625
NCT00976625已完成不适用

Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation

University of Bern2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 1996年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Cardiac function and structure

研究概览

简要总结

Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.

详细描述

Background

Patients with severe aortic regurgitation show eccentric LV hypertrophy and structural changes of the myocardium. Reversibility of functional and structural changes after successful valve replacement may be limited. Persistent diastolic dysfunction has been observed in the present study late after aortic valve replacement. This finding has been explained by incomplete regression of the extra-cellular matrix 7 years after valve replacement. Interstitial fibrosis remains unchanged compared to the preoperative situation but was increased early after operation due to the reduction in LV muscle mass. Regression of LV hypertrophy was 40% after 2 and 55% after 7 years of valve replacement. Myocardial muscle fibers decreased slightly but remained hypertrophied even late after operation. Interstitital fibrosis was found to be positively correlated to myocardial stiffness and inversely to LV ejection fraction.

Thus, persistent diastolic dysfunction with maintained systolic ejection performance can be observed late after successful valve replacement in patients with severe aortic regurgitation. Altered diastolic function has been associated with increased filling pressures during strenuous exercise with signs of dyspnea.

Objective

Evaluation of myocardial structure and function in patients with chronic volume overload before and after valve replacement(LV-remodeling).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe aortic regurgitation
  • Successful valve replacement
  • Informed consent
  • Sinus rhythm
  • No comorbidities
  • No bundle branch block
  • No pregnancy
  • Exclusion Criteria
  • Unwillingness to undergo postop. cath
  • diabetes mellitus
  • arterial hypertension
  • bleeding disorder
  • pulmonary hypertension

排除标准

  • 未提供

结局指标

主要结局

Cardiac function and structure

时间窗: 7-10 years

次要结局

  • LV hypertrophy and passive elastic properties(7-10 years)

研究者

申办方类型
Other

研究点 (2)

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