Heart FailureMITRADVANCENCT05292716
Mitral Regurgitation Treatment in Advanced Heart Failure
A study testing MitraClip in people with Heart Failure and Mitral Regurgitation, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Mitral Regurgitation
- What is being tested?
- MitraClip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2021to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Marianna Adamo
Brescia, Lombardy, 25123
Marianna Adamo, MD, +393897834503, mariannaadamo@hotmail.com
About this study
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.
Read the detailed description
There are no studies comparing MitraClip and optimal medical therapy (OMT) in patients with advanced heart failure (HF).
The aim of this study is to assess the effects of MitraClip on health status, measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), in patients with secondary mitral regurgitation (SMR) and advanced HF.
Secondary aims are to evaluate persistence of such benefits up to 1 year as well as changes in survival, HF hospitalization, functional status, symptoms, echocardiographic parameters, and further optimization in medical therapies.
MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicenter 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. Primary end-point was the absolute change in overall KCCQ summary score (KCCQ-OS) from baseline to 3 months follow-up. A total of 172 patients should be recruited (86 in the device arm and 86 in the control arm. Approximately 20 Italian centers are involved. All screened patients need to be approved by an eligibility committee before randomization. Visit 0 will be performed before randomization. A discharge visit will be performed in patients randomized to the device arm. Visit 1, 2 and 3 will be performed at 3, 6 and 12 months after the randomization in both arms. Transthoracic echocardiography performed during Visit 0, 1, 2 and 3 will be collected and analyzed by an independent Core Laboratory. Adverse events will be adjudicated by an independent committee. Enrolment duration will be of 24 months. The primary completion is the date when the last enrolled subject is assessed for the collection of the primary endpoint. The end of the study is when the last enrolled subject has completed the last follow-up visit.
- Conditions
- Heart Failure, Mitral Regurgitation
- Being tested
- MitraClip
- Keywords
- Heart Failure, Mitral Regurgitation, MitraClip, Optimal medical therapy
- Medical subject headings
- Heart Failure, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClipDevice
MitraClip
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MitraClip |
| Optimal medical therapy | No intervention | Patients randomized to this arm will receive only Optimal medical therapy (OMT) for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 3 months
Secondary outcomes (6)
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]).
Measured: from baseline to 3, 6 and 12 months
All-cause death
Measured: at 3 months, 6 and 12 months
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
Measured: at 3 months, 6 and 12 months
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.
Measured: at 3, 6 and 12 months
Absolute change in KCCQ-OS
Kansas City Cardiomyopathy Questionnaire aims at evaluating quality of life in heart failure patients using a scale including 100 points (from 0 [worst] to 100 [best])
Measured: from baseline to 6 and 12 months
Recurrent HF events
Measured: at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start21 Apr 2021
- Primary completion21 Apr 2025 (estimated)
- Study completion21 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Adamo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292716
- Sponsor's protocol ID
- NP4918
- Acronym
- MITRADVANCE
- Status last verified
- Aug 2024
- First submitted
- 20 Feb 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Regurgitation Treatment in Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT05292716
- Acronym / sponsor ID
- MITRADVANCE / NP4918
- Conditions
- Heart Failure, Mitral Regurgitation
- Keywords
- Heart Failure, Mitral Regurgitation, MitraClip, Optimal medical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 21 Apr 2025 (estimated)
- Study completion
- 21 Apr 2026 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are no studies comparing MitraClip and optimal medical therapy (OMT) in patients with advanced heart failure (HF).
The aim of this study is to assess the effects of MitraClip on health status, measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), in patients with secondary mitral regurgitation (SMR) and advanced HF.
Secondary aims are to evaluate persistence of such benefits up to 1 year as well as changes in survival, HF hospitalization, functional status, symptoms, echocardiographic parameters, and further optimization in medical therapies.
MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicenter 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. Primary end-point was the absolute change in overall KCCQ summary score (KCCQ-OS) from baseline to 3 months follow-up. A total of 172 patients should be recruited (86 in the device arm and 86 in the control arm. Approximately 20 Italian centers are involved. All screened patients need to be approved by an eligibility committee before randomization. Visit 0 will be performed before randomization. A discharge visit will be performed in patients randomized to the device arm. Visit 1, 2 and 3 will be performed at 3, 6 and 12 months after the randomization in both arms. Transthoracic echocardiography performed during Visit 0, 1, 2 and 3 will be collected and analyzed by an independent Core Laboratory. Adverse events will be adjudicated by an independent committee. Enrolment duration will be of 24 months. The primary completion is the date when the last enrolled subject is assessed for the collection of the primary endpoint. The end of the study is when the last enrolled subject has completed the last follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitraClip + Optimal medical therapy | Experimental | Device: MitraClipPatients randomized to this arm will receive percutaneous treatment of secondary mitral regurgitation by MitraClip system and Optimal medical therapy (OMT) for heart failure |
| Optimal medical therapy | No intervention | –Patients randomized to this arm will receive only Optimal medical therapy (OMT) for heart failure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClipMitraClip | Device | MitraClip + Optimal medical therapy |
Primary outcome
Absolute change in overall KCCQ summary score (KCCQ-OS)
Time frame: from baseline to 3 months
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.
6 secondary outcomes
Composite of all-cause death or unplanned HF hospitalization or change in KCCQ-OS
Time frame: from baseline to 3, 6 and 12 months
All-cause death
Time frame: at 3 months, 6 and 12 months
Cardiovascular death
Time frame: at 3 months, 6 and 12 months
Unplanned HF hospitalization
Time frame: at 3, 6 and 12 months
Absolute change in KCCQ-OS
Time frame: from baseline to 6 and 12 months
Recurrent HF events
Time frame: at 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitraClip in people with Heart Failure and Mitral Regurgitation, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in overall KCCQ summary score (KCCQ-OS) (time frame: from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.