TEER In dynaMic sEvere Functional Mitral Regurgitation (TIMER)
ConditionMitral Regurgitation Functional
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSun Yat-sen University
About this trial
Functional mitral regurgitation is a highly dynamic disease. Some patients exhibit only moderate(2+) functional mitral regurgitation at rest, which deteriorates to moderate-to-severe or severe FMR(3+ or 4+) during stress-termed dynamic severe functional mitral regurgitation. Observational studies link this condition to worse outcomes, with mitral valve intervention offering potential benefits; however, high-quality evidence remains lacking.
The Transcatheter Edge-to-Edge Repair In DynaMic sEvere Functional Mitral Regurgitation trial aims to assess the safety and effectiveness of transcatheter edge-to-edge repair plus guideline-directed medical therapy versus guideline-directed medical therapy alone in symptomatic chronic heart failure patients with dynamic severe functional mitral regurgitation, defined as moderate regurgitation at rest deteriorating to severe during handgrip stress echocardiography.
This prospective, multi-center, randomized trial enrolls patients with dynamic severe functional mitral regurgitation confirmed by a core laboratory using handgrip stress echocardiography. Patients are randomized 1:1 to transcatheter edge-to-edge repair plus medical therapy or medical therapy alone. The primary endpoint is the composite of Cardiovascular death or heart failure hospitalization over the entire period.
This trial will provide critical evidence on transcatheter edge-to-edge repair in patients with dynamic severe functional mitral regurgitation, informing future treatment recommendations.
Eligibility criteria
Qualifiers
Clinically significant functional mitral regurgitation (MR=2+ at rest and MR≥3+ under stress) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
Disqualifiers
Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
Status 1 heart transplant or prior orthotropic heart transplantation.
Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
Trial design
Treatments tested in this trial
- TEER
- GDMT
Treatment groups
540 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov