Haemodynamics of Mitral Regurgitation Reduction

NCT05403840 | Unknown

• 1 other identifier: 1.4
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is uncertainty in terms of the superiority of conventional valve surgery or percutaneous transcatheter intervention for the treatment of severe mitral regurgitation (MR) in high risk patients. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood. This study seeks to characterise the physiological changes and functional outcomes of patients undergoing either surgery or transcatheter intervention.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular efficiency as measured by ventricular arterial coupling

  VA coupling is calculated by the ratio of effective arterial elastance (Ea), a measure of afterload, to LV end systolic elastance (Ees), a relatively load independent measure of LV chamber performance. Both these measures are expressed in mmHg/ml and as continuous variables. Normal determined Ea and Ees values in resting subjects are 2.2 ± 0.8 mmHg/ml and 2.3 ± 1.0 mmHg/ml, respectively. When Ea/Ees ratio is approximately equal to 1.0, LV and arterial system are optimally coupled to produce stroke work, a measure of the efficiency of LV work, corresponding to the product of systolic arterial pressure and stroke volume, and related to oxygen consumption. When Ea/Ees ratio is \<1.0, the stroke work remains close to optimal values, but when EA/EES ratio is \>1.0, the stroke work significantly falls, and the LV becomes progressively less efficient. We will compare VA coupling before and after intervention and will be analyzed as continuous variables with appropriate statistical tests.

  From baseline to immediately following intervention and 6 months follow up

Secondary Outcomes (6)

• Change in Left Ventricular End Diastolic Volume (LVEDV)

  Baseline to 6 months post intervention

• Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)

  From baseline to immediately following intervention and 6 months follow up

• Residual Mitral Regurgitation (MR) Severity

  Immediately following intervention and 6 months follow up

• Change in New York Heart Association (NYHA) Functional Class

  Baseline to 6 months follow up

• Change in Six Minute Walk Test (6MWT Distance or 6MWD)

  Baseline to 6 months follow up

Study Arms (2)

MVRR: Patients due to undergo surgical MV repair/replacement

Procedure: Mitral valve surgery

TMVI: Patients due to undergo transcatheter MV intervention

Procedure: Transcatheter mitral valve intervention

Interventions

Mitral valve surgery PROCEDURE

Surgical mitral valve repair or replacement

MVRR: Patients due to undergo surgical MV repair/replacement

Transcatheter mitral valve intervention PROCEDURE

Transcatheter mitral valve repair or replacement

TMVI: Patients due to undergo transcatheter MV intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic severe mitral regurgitation accepted for either surgery or transcatheter valve intervention as standard of care and judged to be at high or prohibitive surgical risk.

You may qualify if:

• Severe mitral regurgitation as per European Society of Cardiology guidelines
• Patients undergoing MVRR or TMVI as standard of care
• Patients at high, prohibitive surgical risk as judged by the Heart Team

You may not qualify if:

• Pregnancy and patients under the age of 18 years
• Congenital heart disease
• Moderate or severe mitral stenosis, aortic, pulmonary valve disease
• Patients currently enrolled in any other study where involvement in this study would involve deviation from either protocol

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College Hospital NHS Trust: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: June 6, 2022
• Primary Completion: June 6, 2024
• Study Completion: January 6, 2025
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share