Mitral Regurgitation Treatment in Advanced Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About this trial
MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicentre study trial enrolling patients with SMR and advanced HF on maximally tolerated standard of care therapies for HF according to the most recent guidelines. Enrolled patients will be randomly assigned, in a 1:1 ratio, to a device arm consisting of MitraClip therapy added to optimal medical therapy (OMT) or a control arm of OMT alone. Approximately 20 Italian high-volume centres will be involved. Enrolment duration will be of 24 months. Follow-up visit will be performed at 3, 6, and 12 months. Primary end-point was the absolute change in overall KCCQ summary score (KCCQ-OS) from baseline to 3 months follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 90 years
Significant secondary mitral regurgitation (effective regurgitant orifice area ≥ 5 30mm2) confirmed at the end of the screening period
Optimal medical therapy (OMT) according to recent guidelines.
Severe and persistent symptoms of HF (NYHA class III or IV)
Disqualifiers
Unfavorable mitral valve anatomy, which implanting investigator judges as not successfully treatable by the MitraClip (i.e. mitral valve area <3 mm2, leaflet length <7 mm)
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
Active infections requiring current antibiotic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
MitraClip
DeviceMitraClip
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: MitraClip + Optimal medical therapyExperimental treatment 1 intervention
Group B: Optimal medical therapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Absolute change in overall KCCQ summary score (KCCQ-OS)
Freedom from all-cause death or unplanned HF events and KCCQ overall summary score (KCCQ-OS) improvement \> or =5 points from baseline, at 3 months.
Time frame
from baseline to 3 monthsSecondary outcomes
1
Composite of all-cause death or unplanned HF hospitalization or change in KCCQ-OS
Unplanned HF hospitalization is defined as Admission to an inpatient unit or ward in the hospital for ≥24 h, including an emergency department stay with symptoms, signs and/or laboratory evidence of worsening heart failure; pulmonary edema, administration of intravenous therapies (loop diuretic agents, vasodilators, inotropic agents, vasopressors) or mechanical heart failure therapies (ultrafiltration, cardiac resynchronization, IABP, LVAD); hospitalizations requiring oxygen therapy. Kansas City Cardiomyopathy Questionnaire (KCCQ) aims at evaluating quality of life in heart failure patients using a scale including 100 points (from 0 \[worst\] to 100 \[best\]).
Time frame
from baseline to 3, 6 and 12 months2
All-cause death
Time frame
at 3 months, 6 and 12 months3
Cardiovascular death
Defined according to MVARC-2 definition as death due to Heart Failure, Myocardial Infarction, Major/Disabling Bleeding, Thromboembolism, Stroke, Arrythmia, Cardiovascular Infection, Cardiac Tamponade, Sudden Death, Device Failure
Time frame
at 3 months, 6 and 12 months4
Unplanned HF hospitalization
Admission to an inpatient unit or ward in the hospital for ≥24 h, including an emergency department stay with symptoms, signs and/or laboratory evidence of worsening heart failure; pulmonary edema, administration of intravenous therapies (loop diuretic agents, vasodilators, inotropic agents, vasopressors) or mechanical heart failure therapies (ultrafiltration, cardiac resynchronization, IABP, LVAD); hospitalizations requiring oxygen therapy.
Time frame
at 3, 6 and 12 monthsOther outcomes
1
Absolute change in EQ-5D
The EQ-5D questionnaire is standardized instrument for measuring generic health status using five dimensions. Each dimension has 5 levels. The final number is included between 0 and 1 (0=worst and 1=best)
Time frame
from baseline to 3, 6 and 12 months2
Patients' Global Impression of Change (PGIC) Scale
The Patients' Global Impression of Change (PGIC) Scale will assess the degree of change in patient's health status in terms of overall improvement (very much improved, much improved, minimally improved, unchanged, minimally worse, much worse, very much worse.
Time frame
at 3, 6 and 12 months3
Change in NYHA class
The New York Heart Association scale include 4 level of heart failure symptoms: 1=No limitation of physical activity, ordinary physical activity does not cause undue fatigue or dyspnea; 2= Slight limitation of physical activity, ordinary physical activity results in fatigue or dyspnea; 3: Marked limitation of physical activity, less than ordinary activity causes fatigue or dyspnea; 4=Symptoms of heart failure at rest
Time frame
from baseline to 3, 6 and 12 months4
Absolute and percentage change in 6-minute walk test (6MWT) distance in meters
Time frame
from baseline to 3, 6 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov