Treatment for Mitral Regurgitation in Patients with Advanced Heart Failure
Mitral Regurgitation Treatment in Advanced Heart Failure
This study is testing if adding MitraClip therapy to standard treatment can help people with advanced heart failure and mitral regurgitation feel better over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Locations | 1 site (Brescia, Lombardy) |
| Trial ID | NCT05292716 on ClinicalTrials.gov |
What this trial studies
MITRADVANCE-HF is a multicenter, randomized trial that evaluates the effectiveness of MitraClip therapy combined with optimal medical therapy in patients suffering from secondary mitral regurgitation and advanced heart failure. Participants will be randomly assigned to receive either the MitraClip intervention or continue with optimal medical therapy alone. The primary outcome will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess changes in health status over a 3-month period, with follow-up visits at 3, 6, and 12 months to monitor additional health metrics. The study aims to recruit 172 patients across approximately 20 centers in Italy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with significant secondary mitral regurgitation and advanced heart failure symptoms despite optimal medical therapy.
Not a fit: Patients with mild or moderate heart failure or those who do not meet the criteria for significant mitral regurgitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and health outcomes for patients with advanced heart failure and secondary mitral regurgitation.
How similar studies have performed: While there have been no direct comparisons of MitraClip and optimal medical therapy in this specific patient population, the approach is innovative and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Advanced heart failure defined as the presence of all the following criteria, despite OMT: * Severe and persistent symptoms of HF (NYHA class III or IV) * Severe cardiac dysfunction defined by a reduced left ventricular ejection fraction (LVEF) ≤35% and/or high BNP or NTproBNP levels (BNP\>125 pg/ml or NTproBNP\>400 pg/ml if sinus rhythm; BNP\>375 pg/ml or NTproBNP\>1200 pg/ml if atrial fibrillation) * Impairment of quality of life (KCCQ \< 75 points) AND severe impairment of exercise capacity with inability to exercise or low 6MWT distance (\<450 meters) or pVO2 (\<14 mL/kg/min or \<50% of predicted) OR at least 1 unplanned visit or hospitalization in the last 12 months, due to HF, and requiring intravenous diuretics and/or inotropes. Exclusion Criteria: * 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 * Transesophageal echocardiography (TEE) contraindicated or at high risk * Untreated significant coronary artery disease requiring revascularization * Iron deficiency defined as serum ferritin \<100 μg/L, or ferritin between 100-299 μg/L and transferrin saturation \<20% and/or intravenous ferric carboxymaltose administration during the 30 days before randomization * Coronary artery bypass graft, percutaneous coronary intervention, transcatheter aortic valve replacement or cardiac resynchronization therapy within the prior 30 days * Pulmonary vein ablation or cardioversion leading to restore of sinus rhythm or AV node ablation in the last 30 days * Myocardial infarction or cerebrovascular accident within prior 30 days * Hemodynamic instability defined as systolic blood pressure \< 90mmHg and cardiogenic shock or need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. * Chronic obstructive pulmonary disease, malignancy, or other comorbidities as the main cause of severe symptoms and impaired quality of life. * Life expectancy \<12 months due to non-cardiac conditions
Where this trial is running
Brescia, Lombardy
- Marianna Adamo — Brescia, Lombardy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.