Treatment Algorithm for Mitral Valve Regurgitation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Mixed mitral pathology, acute IMR

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

110 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment algorithm for mitral valve regurgitation?

The research suggests that early surgical intervention, particularly valve repair, is effective for treating mitral valve regurgitation, especially in asymptomatic patients, as it can restore life expectancy and improve outcomes. Additionally, transcatheter devices are emerging as alternatives for high-risk patients, offering new options for mitral valve repair and replacement. ^{1 2 3 4 5}

How does the drug Ketalar (Special K) differ from other treatments for mitral valve regurgitation?

Ketalar, also known as Special K, is unique because it is primarily known as an anesthetic and pain relief medication, rather than a standard treatment for mitral valve regurgitation. This makes its use in this context novel, as there are no standard drug treatments specifically for this heart condition. ^{6 7 8 9 10}

What is the purpose of this trial?

Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve. Currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. Some surgeons, including Dr. Vincent Chan, the Principal Investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. This study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. This algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. Patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.

Research Team

Vincent Chan, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

This trial is for adults who can consent and have severe ischemic mitral valve regurgitation, a heart condition where the valve leaks due to coronary artery disease. It's not for those with mixed valve issues or acute cases of this condition.

Inclusion Criteria

I have severe leakage in my heart's mitral valve due to poor blood supply.

Exclusion Criteria

I have a mixed condition affecting my mitral valve.

I have a heart valve issue due to a recent blockage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mitral valve repair or replacement based on either surgeon's discretion or an algorithm

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• No Treatment Algorithm
• Treatment Algorithm

Trial Overview The study compares two approaches: one group gets standard care (valve repair/replacement based on surgeon choice), while the other follows a treatment algorithm deciding between repair or replacement based on specific measurements of the mitral valve.

Participant Groups

Group I: Treatment algorithm Experimental Treatment 1 Intervention

Mitral valve will be replaced if posterior leaflet tethering angle \>=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle \<25 degrees

Group II: No treatment algorithm Active Control 1 Intervention

Mitral valve will be repaired or replaced at surgeon's discretion.

Treatment Algorithm is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Pain management
• Sedation

Approved in European Union as Ketalar for:

• Anesthesia
• Pain management
• Sedation

Approved in Canada as Ketalar for:

• Anesthesia
• Pain management
• Sedation

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Valve repair for chronic mitral regurgitation]. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Mitral regurgitation. Timing of surgery or interventional treatment. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Surgical revascularization is associated with maximal survival in patients with ischemic mitral regurgitation: a 20-year experience. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

When to intervene for asymptomatic mitral valve regurgitation. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

The Use of Transcatheter Devices for Mitral Repair and Replacement. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Synthesis of the pyrrolidinone core of KSM-2690 B. [2013]

7. Germany pubmed.ncbi.nlm.nih.gov

Polystyrenesulfonate-catalyzed synthesis of novel pyrroles through Paal-Knorr reaction. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Synthesis of N-methyl-N-[(1S)-1-[(3R)-pyrrolidin-3-yl]ethyl]amine. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Microwave-assisted Paal-Knorr reaction. A rapid approach to substituted pyrroles and furans. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Ring expansions of beta-keto lactones with zinc carbenoids: syntheses of (+)-patulolide A and (+/-)-patulolide B. [2013]