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N/A N=50

The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study

Mitral Regurgitation · Pulmonary Hypertension

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Impaired Post-operative Functional Capacity — 35 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Cardiac catheterisation (Diagnostic_test); Cardiopulmonary exercise testing (Diagnostic_test); Pulmonary function tests (Diagnostic_test); Cardiac MRI (Diagnostic_test); Quality of life survey (Other); Mitral valve operation (Procedure); Myocardial biopsies (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Imperial College London
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Impaired Post-operative Functional Capacity
35
PRIMARY
Imaging Data
0.31
SECONDARY
Right Heart Catheterisation
SECONDARY
Quality of Life as Assessed by SF36 Survey
64.3; 62.9; 74.9
SECONDARY
Myocardial Histology
8.9; 8.4; 3.7; 7.4

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.

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03155373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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