The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study

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.

Conditions

• Mitral Regurgitation
• Pulmonary Hypertension

Interventions

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

Sponsors & Collaborators

• Imperial College London

  lead OTHER

Principal Investigators

• Prakash Punjabi, FRCS · Imperial College London

• Simon Gibbs, FRCP · Imperial College London

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-15

Primary Completion

2019-03-01

Completion

2019-03-01

Countries

• United Kingdom

Study Locations