跳至主要内容
临床试验/NCT03549052
NCT03549052Unknown不适用

Right Ventricular Function After Mitral Valve Replacement in Rheumatic Heart Disease Patients With Pulmonary Hypertension: Short Term Follow up

Assiut University0 个研究点目标入组 120 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
The correlation between echocardiographic parameters of the RV, measured with TTE , preoperative and short term post operative

研究概览

简要总结

Rheumatic heart disease remains a major health problem in developing countries. It is the most important sequel of rheumatic fever and occurs in about 30% of patients with rheumatic fever.Rheumatic heart disease presents with different degrees of pancarditis and associated valve failure. Involvement of the mitral leaflets can cause mitral regurgitation (MR) or stenosis and eventually can lead to heart failure. Mitral repair or replacement is therefore recommended before left ventricular (LV) dysfunction develops.

Study Objectives/Specific Aims Overall Goal: To determine the benefit the patient with pulmonary hypertension will get from mitral valve replacement as regard function improvement and remodeling of the right ventricle.

  • Objective1: Identify risk factors that are predictive of outcomes.(Type and severity of Mitral valve pathology , severity of pulmonary hypertension, tricuspid regurge, preoperative RV dysfunction)
  • Objective2: Determine the value of management strategies (Mitral valve replacement in pulmonary hypertension i.e. : decrease RV pressure overload and enhance RV remodeling)
  • Objective3: Assessment of the outcomes clinically & Echocardiographically : postoperative results during hospital stay and follow up (short term up to 3 months).

详细描述

In 1994, it was estimated that 12 million individuals had RF and RHD worldwide , and at least 3 million had congestive heart failure (CHF) that required repeated hospital admissions. A large section of the individuals with CHF required cardiac valve surgery within 5-10 years . The mortality rate for RHD varied from 0.5 per 100 000 population in Denmark, to 8.2 per 100 000 population in China , and the estimated annual number of deaths from RHD for 2000 was 332000 worldwide . The mortality rate per 100 000 population varied from 1.8 in the WHO Region of the Americas, to 7.6 in WHO South-East Asia Region. The disability-adjusted life years (DALYs)1 lost to RHD ranged from 27.4 DALYs per 100 000 population in the WHO Region of the Americas, to 173.4 per 100 000 population in the WHO South-East Asia Region. An estimated 6.6 million DALYs are lost per year worldwide.

THE PATHOLOGY OF RHEUMATIC MITRAL VALVE DISEASE Rheumatic mitral valves shows a different set of lesions by comparison with degenerative valves, because of the characteristic inflammatory process, which results in thickening of the leaflets and other components of the mitral valve apparatus, of variable degrees, and distorts and impairs the movements of the valve. So, the disease appears here in two forms - stenosis and regurgitation, or a combination of both.

In the case of valve regurge, the most frequent lesion is prolapse of the anterior leaflet, which is present in more than 90% of young patients and is most often caused by elongated chordae to its central and medial areas (A2 and A3). In contrast to degenerative disease, posterior leaflet prolapse is practically not found, except in cases with ruptured chordae due to infective endocarditis. On the contrary, this leaflet is often shortened in its width, sometimes resumed to a very narrow and thick strip of tissue. In more complicated cases, the chordae may be thick and retracted, as may also be the papillary muscles, and the commissures may be fused in varying degrees. Often, the leaflets and subvalvular apparatus are a continuous mass of fibrous tissue. Lastly, the annulus is dilated in 95% of the patients. It is widely accepted that dilatation occurs essentially in the posterior segment of the annulus, although there is some evidence that it may also occur in the anterior segment, especially in dilated cardiomyopathy.

Pulmonary hypertension and valvular heart disease Valvular Heart Disease VHD is a common etiology of pulmonary hypertension, which may result from many mechanisms as an increase in pulmonary vascular resistance, pulmonary blood flow, or pulmonary venous pressure. The chronic rise in pulmonary arterial pressure (PAP) often leads to right ventricular (RV) pressure overload and subsequent RV failure. When present, PH is a marker of poor outcome in VHD. Assessment of the presence and severity of Pulmonary hypertension thus has an important role in the risk stratification and therapeutic management of VHD.

The sure diagnosis of PH related to VHD is based on the following criteria: mean PAP 25 mm Hg together with an abnormally high pulmonary capillary wedge pressure (PCWP) >15 mm Hg or left ventricular (LV) end-diastolic pressure >18 mm Hg in the context of significant VHD. When pulmonary venous congestion is the main determinant of PH, PH is named isolated post-capillary PH or pulmonary venous hypertension.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All ages will be accepted.
  • •Isolated mitral valve lesion either stenosis or regurge.
  • •Good LV function (EF <45%).
  • •Any degree of tricuspid valve regurge..

排除标准

  • •Concomitant Aortic valve lesion needs replacement.
  • •Poor LV function (Low EF> 45%).
  • •Other causes of pulmonary hypertension i.e.: (Chronic obstructive or restrictive pulmonary disease, connective tissue disease and chronic thromboembolism).
  • •Emergency and Redo operations.

结局指标

主要结局

The correlation between echocardiographic parameters of the RV, measured with TTE , preoperative and short term post operative

时间窗: Baseline-1 Week-3 months

change in TAPSE (Tricuspid annular plane systolic excursion )

次要结局

  • postoperative Response in right ventricular function parameter S' Change in S'(Baseline-1 Week-3 months)
  • Postoperative Response in right ventricular function parameter RVFAC(Baseline-1 Week-3 months)
  • Postoperative Response in right ventricular function parameter pulmonary artery systolic pressure(Baseline-1 Week-3 months)
  • Postoperative right atrial pressure assesment(Baseline-1 Week-3 months)
  • Evaluation of reverse right ventricle (RV) remodelling(Baseline-1 Week-3 months)
  • Residual TR(Baseline-1 Week-3 months)

研究者

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

Ahmed M. Nasr

Assistant Lecturer Cardiothoracic surgery

Assiut University

相似试验