Mitral Regurgitation Treatment in Advanced Heart Failure

NCT05292716 | Recruiting DMC

• 1 other identifier: NP4918
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Mitral Regurgitation

Keywords

Heart Failure; Mitral Regurgitation; MitraClip; Optimal medical therapy

Outcome Measures

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.

  from baseline to 3 months

Secondary Outcomes (6)

• Composite of all-cause death or unplanned HF hospitalization or change in KCCQ-OS

  from baseline to 3, 6 and 12 months

• All-cause death

  at 3 months, 6 and 12 months

• Cardiovascular death

  at 3 months, 6 and 12 months

• Unplanned HF hospitalization

  at 3, 6 and 12 months

• Absolute change in KCCQ-OS

  from baseline to 6 and 12 months

Other Outcomes (10)

• Absolute change in EQ-5D

  from baseline to 3, 6 and 12 months

• Patients' Global Impression of Change (PGIC) Scale

  at 3, 6 and 12 months

• Change in NYHA class

  from baseline to 3, 6 and 12 months

Study Arms (2)

MitraClip + Optimal medical therapy

EXPERIMENTAL

Patients randomized to this arm will receive percutaneous treatment of secondary mitral regurgitation by MitraClip system and Optimal medical therapy (OMT) for heart failure

Device: MitraClip

Optimal medical therapy

NO INTERVENTION

Patients randomized to this arm will receive only Optimal medical therapy (OMT) for heart failure

Interventions

MitraClip DEVICE

MitraClip

MitraClip + Optimal medical therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Marianna Adamo

Brescia, Lombardy, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 23, 2022
• Study Start: April 21, 2021
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

IT (1)