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The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study (RIPCOM1)

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ClinicalTrials.gov Identifier: NCT03155373
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

Mitral regurgitation (MR) is a prevalent valvular heart pathology. Indications for surgery include symptoms, impaired left ventricular function or enlarging dimensions, new onset atrial fibrillation, pulmonary hypertension, asymptomatic status with a high likelihood of success.

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.


Condition or disease Intervention/treatment
Mitral Regurgitation Pulmonary Hypertension Diagnostic Test: Cardiac catheterisation Diagnostic Test: Cardiopulmonary exercise testing Diagnostic Test: Pulmonary function tests Diagnostic Test: Cardiac MRI Other: Quality of life survey Procedure: Mitral valve operation Procedure: Myocardial biopsies

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : March 1, 2019

Group/Cohort Intervention/treatment
A
Asymptomatic/mild symptomatic patients with normal pre-operative left ventricular function (defined as left ventricular ejection fraction >60%)
Diagnostic Test: Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation

Diagnostic Test: Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing

Diagnostic Test: Pulmonary function tests
Pre and post-operative pulmonary function tests

Diagnostic Test: Cardiac MRI
Pre and post-operative cardiac MRI

Other: Quality of life survey
Pre and post-operative quality of life survey (SF36)

Procedure: Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery

Procedure: 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%)
Diagnostic Test: Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation

Diagnostic Test: Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing

Diagnostic Test: Pulmonary function tests
Pre and post-operative pulmonary function tests

Diagnostic Test: Cardiac MRI
Pre and post-operative cardiac MRI

Other: Quality of life survey
Pre and post-operative quality of life survey (SF36)

Procedure: Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery

Procedure: 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%)
Diagnostic Test: Cardiac catheterisation
Pre-operative left heart catheterisation +/- right heart catheterisation

Diagnostic Test: Cardiopulmonary exercise testing
Pre and post-operative cardiopulmonary exercise testing

Diagnostic Test: Pulmonary function tests
Pre and post-operative pulmonary function tests

Diagnostic Test: Cardiac MRI
Pre and post-operative cardiac MRI

Other: Quality of life survey
Pre and post-operative quality of life survey (SF36)

Procedure: Mitral valve operation
Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery

Procedure: Myocardial biopsies
Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery




Primary Outcome Measures :
  1. Cardiopulmonary exercise testing [ Time Frame: 1 year ]
    Changes in cardiopulmonary exercise parameters after surgery and correlation with imaging markers of left ventricular function

  2. Imaging data [ Time Frame: 1 year ]
    Transthoracic echocardiogram and cardiac MRI parameters


Secondary Outcome Measures :
  1. Right heart catheterisation [ Time Frame: Pre-op ]
    Accuracy of measurements of pre-op pulmonary artery pressures against the gold standard of right heart catheterisation

  2. Quality of life [ Time Frame: 1 year ]
    Changes in quality of life measured on the SF36 survey after surgery

  3. Myocardial histology [ Time Frame: At surgery ]
    Quantification of myocardial fibrosis on right and left ventricular biopsies


Biospecimen Retention:   Samples Without DNA
Left and right ventricular biopsies taken at time of clinically indicated surgery


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing cardiac surgery for severe primary/degenerative mitral regurgitation under the current guidelines.
Criteria

Inclusion Criteria:

Patients listed for surgery for severe primary mitral regurgitation +/- concomitant coronary artery bypass grafting for bystander disease +/- tricuspid valve surgery +/- atrial fibrillation surgery.

Exclusion Criteria:

Secondary mitral regurgitation. Significant history of ischaemic heart disease eg. angina. Age <18 years or >85 years. Critical preoperative status with multi-organ dysfunction. Emergency cardiac surgical intervention. Pregnancy. Unable to give informed consent or unwilling to participate in research. Patients with definite contraindication for MRI would be excluded from the cardiac MRI element of the study.

Patients we are unable to take adequate biopsies due to technical difficulties would be excluded from the myocardial biopsy element of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155373


Contacts
Contact: Jonathan Afoke, MRCS 02033132026 jonathan.afoke@nhs.net
Contact: Prakash Punjabi, FRCS 02033132026 p.punjabi@imperial.ac.uk

Locations
United Kingdom
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Jonathan Afoke, MBBS MRCS    02033132026    jonathan.afoke@nhs.net   
Principal Investigator: Prakash Punjabi, FRCS         
Principal Investigator: Simon Gibbs, FRCP         
Sub-Investigator: Gajen Kanaganayagam, FRCP         
Sub-Investigator: Joseph Boyle, PhD         
Sub-Investigator: Jonathan Afoke, MRCS         
Sub-Investigator: Anne Marie Tiernan, BSc         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Prakash Punjabi, FRCS Imperial College London
Principal Investigator: Simon Gibbs, FRCP Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03155373     History of Changes
Other Study ID Numbers: 16HH3639
16/LO/2127 ( Other Identifier: REC )
199676 ( Other Identifier: IRAS )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
Cardiopulmonary exercise testing

Additional relevant MeSH terms:
Hypertension, Pulmonary
Mitral Valve Insufficiency
Lung Diseases
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases