CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Cardiac catheterisation +6 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03155373
NCT03155373N/ACompleted

The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease

Imperial College London·observational·Posted May 16, 2017·Updated Feb 28, 2023

In Brief

An observational study evaluating Cardiac catheterisation, Cardiopulmonary exercise testing, and 5 other interventions for Mitral Regurgitation and Pulmonary Hypertension. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 16, 2017
Enrollment StartFeb 15, 2017
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.1 years ago

Interventions

Cardiac catheterisationother

Pre-operative left heart catheterisation +/- right heart catheterisation

Cardiopulmonary exercise testingother

Pre and post-operative cardiopulmonary exercise testing

Pulmonary function testsother

Pre and post-operative pulmonary function tests

Cardiac MRIother

Pre and post-operative cardiac MRI

Quality of life surveyother

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

Mitral valve operationprocedure

Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery

Myocardial biopsiesprocedure

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