The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study
NCT ID: NCT03155373
Last Updated: 2023-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
50 participants
OBSERVATIONAL
2017-02-15
2019-03-01
Brief Summary
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Asymptomatic severe primary MR can be initially monitored without impairing long term survival. However, significant symptoms or impairment of left ventricular function is associated with worse prognosis due to long term heart failure. Some physicians wait for early symptoms before referring for surgery and this is reflected by a great variation in referral patterns, but symptomatic status is subjective and difficult to assess. Nearly all of the surgical indications are based on expert opinion rather than significant evidence base.
The primary aim of this project is to improve the current guidelines for surgery for primary MR by finding an objective marker of functional capacity which correlates with surrogates of prognosis and detects early decline, but returns to normal after surgery.
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Detailed Description
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The fulcrum point between asymptomatic status and symptomatic status at which patients would derive prognostic benefit and thus should be referred for surgery on prognostic grounds still remains unclear and controversial. Although elective mitral valve repair carries a low risk of mortality, it has been demonstrated that asymptomatic patients with severe degenerative MR can be safely followed up before becoming symptomatic or reaching cutoff values for left ventricular dimensions, size or pulmonary hypertension; with no significant difference with expected survival. As a result, it is debatable whether prophylactic surgery for all patients with asymptomatic severe degenerative MR derives prognostic benefit.
At the other end of the clinical spectrum, the increased operative mortality and worse long term prognosis of symptomatic patients is well proven. Patients with New York Heart Association Class III or IV status have excessive operative mortality and significantly increased mortality at 10 years. Both this study and another have demonstrated that preoperative ejection fraction is an independent predictor of long term survival. Although this evidence base does not support prophylactic surgery on asymptomatic patients, it does highlight the importance of avoiding the long term sequelae of MR in causing symptomatic status or left ventricular impairment. Hence attention has turned to objective markers or investigations independent of symptomatic status that may be subjectively assessed in the early phases; to help identify patients who would prognostically benefit from earlier surgical intervention.
In summary, severe mitral regurgitation is a common valvular pathology that causes a significant burden of disease. Current guidelines for timing of operative intervention are mostly based on expert opinion rather than randomised trials or studies. The ideal tipping point investigation will be an objective marker of functional capacity which correlates with known surrogates of survival such as left ventricular function; and detects early decline, but returns to normal after successful surgery. The improved evidence base will create an epidemiological shift in patterns of referring for mitral valve surgery and reduce the burden of disease of heart failure.
Patients will undergo the following investigations:
Right heart catheterisation- It is the usual gold standard practice at our institution for patients to have a right heart catheterisation before being referred for surgery. Those who have not had one may be referred to the Department of Cardiology at Hammersmith Hospital for this test.
Cardiac MRI- patients will have a T1 weighted cardiac MRI. One strength of cardiac MRI over transthoracic echocardiogram is objective measurements of right heart function. Parameters measured will be ventricular ejection fraction and dimensions, patterns of myocardial fibrosis.
Cardiopulmonary exercise testing (CPEX)- CPEX is a quantitative and validated method of assessing cardiorespiratory function and exercise capacity with commonly measured variables including maximal oxygen consumption (VO2 max) and the clearance of carbon dioxide during exercise (Ve/VCO2). The patient's gaseous exchange is monitored during a 3 minute rest period, a three minute "rolling basal" period when they perform exercise on a bicycle with no load; and subsequently during the exercise phase when the work load increases at a rate of 30 Watts per minute. Exercise continues until the patient has to stop or achieves predicted maximum heart rate.
Pulmonary function tests- Patients will have routine spirometry tests and also assessment of transfer factor.
Transthoracic echocardiogram- It is normal practice for patients to have an echocardiogram at preassessment clinic to assess biventricular function, dimensions and cardiac structural disease.
Quality of life questionnaire- Patients will be asked to fill out a validated questionnaire (SF-36 health survey).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
Asymptomatic/mild symptomatic patients with normal pre-operative left ventricular function (defined as left ventricular ejection fraction \>60%)
Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation
Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing
Pulmonary function tests
Pre and post-operative pulmonary function tests
Cardiac MRI
Pre and post-operative cardiac MRI
Quality of life survey
Pre and post-operative quality of life survey (SF36)
Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery
Myocardial biopsies
Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
B
Symptomatic patients with normal pre-operative left ventricular function (defined as left ventricular ejection fraction greater than or equal to 60%)
Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation
Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing
Pulmonary function tests
Pre and post-operative pulmonary function tests
Cardiac MRI
Pre and post-operative cardiac MRI
Quality of life survey
Pre and post-operative quality of life survey (SF36)
Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery
Myocardial biopsies
Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
C
Patients with impaired pre-operative left ventricular function (defined as left ventricular ejection fraction \<60%)
Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation
Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing
Pulmonary function tests
Pre and post-operative pulmonary function tests
Cardiac MRI
Pre and post-operative cardiac MRI
Quality of life survey
Pre and post-operative quality of life survey (SF36)
Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery
Myocardial biopsies
Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
Interventions
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Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation
Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing
Pulmonary function tests
Pre and post-operative pulmonary function tests
Cardiac MRI
Pre and post-operative cardiac MRI
Quality of life survey
Pre and post-operative quality of life survey (SF36)
Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery
Myocardial biopsies
Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Patients we are unable to take adequate biopsies due to technical difficulties would be excluded from the myocardial biopsy element of the study.
18 Years
85 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Prakash Punjabi, FRCS
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Simon Gibbs, FRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Hammersmith Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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16/LO/2127
Identifier Type: OTHER
Identifier Source: secondary_id
199676
Identifier Type: OTHER
Identifier Source: secondary_id
16HH3639
Identifier Type: -
Identifier Source: org_study_id
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