Trial Outcomes & Findings for The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study (NCT NCT03155373)

Results Overview

Dichotomic variable of post-operative left ventricular ejection \< 50% and/or post-operative percentage predicted peak VO2 \<= 84%

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2023-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Cohort Patients undergoing surgery under current guidelines for surgery for primary MR.
Overall Study STARTED	50
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Cohort Patients undergoing surgery under current guidelines for surgery for primary MR.
Overall Study No longer required surgery	1
Overall Study Protocol Violation	1
Overall Study Death	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Cohort n=43 Participants Patients undergoing surgery under current guidelines for surgery for primary MR.
Age, Continuous	61.2 years STANDARD_DEVIATION 12.9 • n=43 Participants
Sex: Female, Male Female	15 Participants n=43 Participants
Sex: Female, Male Male	28 Participants n=43 Participants
Region of Enrollment United Kingdom	43 participants n=43 Participants

PRIMARY outcome

Timeframe: 1 year

Dichotomic variable of post-operative left ventricular ejection \< 50% and/or post-operative percentage predicted peak VO2 \<= 84%

Outcome measures

Outcome measures
Measure	Overall Cohort n=43 Participants Patients meeting current international guidelines indications for surgery for primary mitral regurgitation Cardiac catheterisation: Pre-operative left heart catheterisation +/- right heart catheterisation Cardiopulmonary exercise testing: Pre and post-operative cardiopulmonary exercise testing Pulmonary function tests: Pre and post-operative pulmonary function tests Cardiac MRI: Pre and post-operative cardiac MRI Quality of life survey: Pre and post-operative quality of life survey (SF36) Mitral valve operation: Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery Myocardial biopsies: Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
Impaired Post-operative Functional Capacity	35 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Correlation co-efficient on linear model between LVEF measurement on transthoracic echocardiogram against cardiac MRI

Correlation between transthoracic echocardiogram and cardiac MRI parameters

Outcome measures

Outcome measures
Measure	Overall Cohort n=43 Participants Patients meeting current international guidelines indications for surgery for primary mitral regurgitation Cardiac catheterisation: Pre-operative left heart catheterisation +/- right heart catheterisation Cardiopulmonary exercise testing: Pre and post-operative cardiopulmonary exercise testing Pulmonary function tests: Pre and post-operative pulmonary function tests Cardiac MRI: Pre and post-operative cardiac MRI Quality of life survey: Pre and post-operative quality of life survey (SF36) Mitral valve operation: Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery Myocardial biopsies: Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
Imaging Data	0.31 r value

SECONDARY outcome

Timeframe: Pre-op

Population: Data were not collected since right heart catheterisation was not performed due to adding an extra invasive investigation on the patients after they had already met the guidelines for surgery.

Accuracy of measurements of pre-op pulmonary artery pressures against the gold standard of right heart catheterisation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (preoperatively), early follow up (6 weeks after surgery), late follow up (6 months after surgery)

Population: Physical functioning on SF36 quality of life questionnaire from 0 (worst) to 100 (best) at baseline (preoperatively), early follow up (6 weeks after surgery), late follow up (6 months after surgery)

Changes in quality of life measured on the SF36 survey after surgery

Outcome measures

Outcome measures
Measure	Overall Cohort n=43 Participants Patients meeting current international guidelines indications for surgery for primary mitral regurgitation Cardiac catheterisation: Pre-operative left heart catheterisation +/- right heart catheterisation Cardiopulmonary exercise testing: Pre and post-operative cardiopulmonary exercise testing Pulmonary function tests: Pre and post-operative pulmonary function tests Cardiac MRI: Pre and post-operative cardiac MRI Quality of life survey: Pre and post-operative quality of life survey (SF36) Mitral valve operation: Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery Myocardial biopsies: Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
Quality of Life as Assessed by SF36 Survey Pre-operative	64.3 Score on the scale Standard Deviation 26.6
Quality of Life as Assessed by SF36 Survey Early follow up	62.9 Score on the scale Standard Deviation 25.4
Quality of Life as Assessed by SF36 Survey Late follow up	74.9 Score on the scale Standard Deviation 23.7

SECONDARY outcome

Timeframe: At surgery

Population: 15 patients consented to myocardial biopsies at time of surgery

Quantification of myocardial fibrosis on right and left ventricular biopsies

Outcome measures

Outcome measures
Measure	Overall Cohort n=15 Participants Patients meeting current international guidelines indications for surgery for primary mitral regurgitation Cardiac catheterisation: Pre-operative left heart catheterisation +/- right heart catheterisation Cardiopulmonary exercise testing: Pre and post-operative cardiopulmonary exercise testing Pulmonary function tests: Pre and post-operative pulmonary function tests Cardiac MRI: Pre and post-operative cardiac MRI Quality of life survey: Pre and post-operative quality of life survey (SF36) Mitral valve operation: Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery Myocardial biopsies: Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
Myocardial Histology RV in peak VO2>80%	8.9 % interstitial fibrosis Standard Deviation 2.2
Myocardial Histology RV in peak VO2 <80%	8.4 % interstitial fibrosis Standard Deviation 4.2
Myocardial Histology LV in peak VO2 >80%	3.7 % interstitial fibrosis Standard Deviation 2.3
Myocardial Histology LV in peak VO2 <80%	7.4 % interstitial fibrosis Standard Deviation 5.3

Adverse Events

Overall Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Afoke

Imperial College Healthcare NHS Trust

Phone: 02033132026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place