Mitral RegurgitationSTRESS-MRNCT05403840
Haemodynamics of Mitral Regurgitation Reduction
An observational study of Mitral Regurgitation, run by Guy's and St Thomas' NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Mitral valve surgery and Transcatheter mitral valve intervention
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2022to 6 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Comparative STudy chaRacterising the Physiological changEs Induced by Surgical and tranScatheter Mitral Regurgitation Reduction (STRESS-MR)
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.
Read the detailed description
Conventional surgery for mitral regurgitation (MR) in high risk patients is associated with reduced benefit and increased risk of perioperative complications.Percutaneous transcatheter intervention (edge to edge repair) is an alternative treatment option is associated with clinical benefit and reduced peri-procedural risk. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood.
This is a a prospective observational study, involving patients with severe MR undergoing mitral valve surgery (MVRR) and transcatheter intervention (TMVI) as standard of care being recruited into two separate cohorts. Patients will undergo investigations at baseline, in hospital post-operative, and at 6 months to characterise cardiac structure and function.
- Conditions
- Mitral Regurgitation
- Being tested
- Mitral valve surgery, Transcatheter mitral valve intervention
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve surgeryProcedure or surgery
Surgical mitral valve repair or replacement
Transcatheter mitral valve interventionProcedure or surgery
Transcatheter mitral valve repair or replacement
| Study group | Role | What they receive |
|---|---|---|
| MVRR: Patients due to undergo surgical MV repair/replacement | Not described Receives: Procedure: Mitral valve surgery | |
| TMVI: Patients due to undergo transcatheter MV intervention | Not described Receives: Procedure: Transcatheter mitral valve intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to immediately following intervention and 6 months follow up
Secondary outcomes (6)
Change in Left Ventricular End Diastolic Volume (LVEDV)
Paired data comparing the Change in LVEDV at baseline vs 6 months
Measured: Baseline to 6 months post intervention
Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
Measured: From baseline to immediately following intervention and 6 months follow up
Residual Mitral Regurgitation (MR) Severity
MR Severity Grading done by Quantitative Doppler Echocardiography
Measured: Immediately following intervention and 6 months follow up
Change in New York Heart Association (NYHA) Functional Class
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.
Measured: Baseline to 6 months follow up
Change in Six Minute Walk Test (6MWT Distance or 6MWD)
The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Measured: Baseline to 6 months follow up
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Measured: Baseline to 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start6 Jun 2022 (estimated)
- Primary completion6 Jun 2024 (estimated)
- Study completion6 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, Omar Chehab, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403840
- Sponsor's protocol ID
- 1.4
- Acronym
- STRESS-MR
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative STudy chaRacterising the Physiological changEs Induced by Surgical and tranScatheter Mitral Regurgitation Reduction (STRESS-MR)
- ClinicalTrials.gov ID
- NCT05403840
- Acronym / sponsor ID
- STRESS-MR / 1.4
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Study start
- 6 Jun 2022 (estimated)
- Primary completion
- 6 Jun 2024 (estimated)
- Study completion
- 6 Jan 2025 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Conventional surgery for mitral regurgitation (MR) in high risk patients is associated with reduced benefit and increased risk of perioperative complications.Percutaneous transcatheter intervention (edge to edge repair) is an alternative treatment option is associated with clinical benefit and reduced peri-procedural risk. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood.
This is a a prospective observational study, involving patients with severe MR undergoing mitral valve surgery (MVRR) and transcatheter intervention (TMVI) as standard of care being recruited into two separate cohorts. Patients will undergo investigations at baseline, in hospital post-operative, and at 6 months to characterise cardiac structure and function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve surgerySurgical mitral valve repair or replacement | Procedure or surgery | MVRR: Patients due to undergo surgical MV repair/replacement |
| Transcatheter mitral valve interventionTranscatheter mitral valve repair or replacement | Procedure or surgery | TMVI: Patients due to undergo transcatheter MV intervention |
Primary outcome
Change in left ventricular efficiency as measured by ventricular arterial coupling
Time frame: From baseline to immediately following intervention and 6 months follow up
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.
6 secondary outcomes
Change in Left Ventricular End Diastolic Volume (LVEDV)
Time frame: Baseline to 6 months post intervention
Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
Time frame: From baseline to immediately following intervention and 6 months follow up
Residual Mitral Regurgitation (MR) Severity
Time frame: Immediately following intervention and 6 months follow up
Change in New York Heart Association (NYHA) Functional Class
Time frame: Baseline to 6 months follow up
Change in Six Minute Walk Test (6MWT Distance or 6MWD)
Time frame: Baseline to 6 months follow up
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline to 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No. To be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular efficiency as measured by ventricular arterial coupling (time frame: From baseline to immediately following intervention and 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.