The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study
Mitral Regurgitation · Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03155373 ↗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
| Outcome | Result | p-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
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.
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.