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Heart Failure
+1

Mitral Regurgitation Treatment in Advanced Heart Failure

Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

About this trial

Last updated 3 years ago

Study ID

NP4918

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 90 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Age between 18 and 90 years

- Significant secondary mitral regurgitation (effective regurgitant orifice area ≥ 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 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)
- At least 1 unplanned visit or hospitalization in the last 12 months, due to HF, and requiring intravenous diuretics and/or inotropes
- Severe impairment of quality of life (KCCQ < 75 points)
- Severe impairment of exercise capacity with inability to exercise or low 6MWT distance (<300 meters) or pVO2 (<12-14 mL/kg/min or <50% of predicted)
No

Exclusion Criteria

- Unfavorable mitral valve anatomy, which implanting investigator judges as not successfully treatable by the MitraClip

- 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

- 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

Locations

Location

Status

Recruiting