Przewidywanie odwrotnej przebudowy i wyników u pacjentów z ciężką wtórną niedomykalnością zastawki mitralnej poddawanych przezcewnikowej naprawie zastawki mitralnej od krawędzi do krawędzi (PRE-MITRA)
The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair.
Przegląd badań
Status
Warunki
Szczegółowy opis
Diametrically opposed results of the COAPT- and the MITRA-FR trial have demonstrated the need for additional evidence in the field of transcatheter mitral edge-to-edge repair. Reverse left ventricular remodeling after treatment of severe secondary mitral regurgitation can indicate treatment response and is associated with positive outcomes.
However, so far it is reverse remodeling, respectively treatment response is difficult to predict, which complicates patient selection for mitral edge-to-edge repair. Previous studies have shown, that focal (late gadolinium enhancement (LGE)) but not diffuse myocardial fibrosis (T1 mapping and extracellular volume fraction (ECV)) burden quantification using CMR predicts reverse left ventricular remodeling following cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction (HFrEF). On the other hand, myocardial T1 mapping was predictive for beneficial left ventricular remodeling after long-term heart failure therapy. Furthermore, in patients with HFrEF, LGE is associated with clinical outcome and an incremental predictive value to left ventricular dimensions and function. However, as only 1/3 of HFrEF patients show LGE, subtle fibrosis might be missed. Recently the investigators have shown that different novel fibrosis detection techniques (naive T1 mapping, mean ECV and λGd being the delta of pre- and post T1 mapping and ECV calculation) all demonstrated strong association with outcome in patients with heart failure.
The investigators' hypothesis is that these markers (CMR tissue characterization and myocardial function analysis acquired by a CMR feature tracking) might also be helpful in predicting reverse remodeling after transcatheter mitral edge-to-edge repair. This project might help to understand the pathophysiology of the disease in patients with secondary mitral regurgitation, improve risk stratification in this clinical setting, and optimize selection of patients who benefit from transcatheter mitral edge-to-edge repair.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Bern, Szwajcaria, 3010
- Department of Cardiology, University Hospital Bern, Inselspital, Bern
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patients with severe secondary MR characterized, according to the European guidelines and recommendations, by a regurgitant volume ≥30 mL/beat or an effective regurgitant orifice ≥20 mm².
- Symptomatic patients with New York Heart Association Class ≥II.
- Left ventricular ejection fraction between 15% and 50%.
- Optimal standard of care therapy for heart failure according to investigator.
- Not eligible for a mitral surgery intervention according to the Heart Team.
- Patients who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements.
Exclusion Criteria:
- Participants younger than 18 years
- Pregnancy or breastfeeding
- Severe impaired renal function (GFR < 15 ml/min)
- Patients with untreated severe concomitant valve disease (e.g. severe tricuspid valve regurgitation, aortic stenosis)
- The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
- The patient has contraindications to CMR, including: Implanted non-CMR conditional metallic implants, pacemaker, intracardiac defibrillator, neurostimulator, epicardial pacemaker leads, or any abandoned leads, ferromagnetic aneurysm clip, ferromagnetic halo device, cochlear implants, implanted infusion pumps or severe claustrophobia
- The patient is clinically unstable or has stage D congestive heart failure or inability to lay flat for 60 minutes
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Treatment Arm
Patients undergoing transcatheter mitral edge-to-edge repair in this single-arm study. |
CMR image acquisition with previously mentioned analysis Included patients will undergo Transcatheter mitral edge-to-edge repair. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Rate of patients with reverse remodeling after 12 months
Ramy czasowe: 12 months after mitral edge-to-edge repair
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Defined as ≥10% reduction in left ventricular end-diastolic volume in patients with successful MR reduction to grade 2+ or less 12 months after mitral edge-to-edge repair assessed by echocardiography. |
12 months after mitral edge-to-edge repair
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Rate of patients with procedural and device success
Ramy czasowe: 24 months after mitral edge-to-edge repair
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Procedural and device success as defined according to the criteria of the Mitral Valve Academic Research Consortium |
24 months after mitral edge-to-edge repair
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Rate of patients with reverse remodeling after 6 and 24 months
Ramy czasowe: 6 and 24 months after mitral edge-to-edge repair
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Reverse remodeling at 6 and 24 months, defined according to previously mentioned criteria. |
6 and 24 months after mitral edge-to-edge repair
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Change of left ventricular sphericity index
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Echocardiographic assessment of LV sphericity index measured using the LV short/long axis dimension ratio in the end-diastolic four-chamber apical view. |
6, 12 and 24 months after mitral edge-to-edge repair
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Change in NT-proBNP levels
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Change in NT-proBNP levels as an indirect sign of changes in left ventricular filling pressure, fibrosis and reverse remodeling will be measured in clinically indicated follow-ups at different time points after the intervention. |
6, 12 and 24 months after mitral edge-to-edge repair
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All cause death
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Occurence of death from any cause |
6, 12 and 24 months after mitral edge-to-edge repair
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Cardiovascular death
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Occurence of death from cardiovascular reason |
6, 12 and 24 months after mitral edge-to-edge repair
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Rate of patients with heart-failure related hospitalization
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Hospitalizations for heart failure within the observation time will be systematically recorded. |
6, 12 and 24 months after mitral edge-to-edge repair
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Change in NYHA class
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Change in NYHA class ≥ +/- 1 compared to baseline NYHA-class before mitral edge-to-edge repair. |
6, 12 and 24 months after mitral edge-to-edge repair
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Change in myocardial strain
Ramy czasowe: Within 24 months after mitral edge-to-edge repair
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Clinically indicated follow-up imaging (CMR) will be analyzed by CMR feature tracking |
Within 24 months after mitral edge-to-edge repair
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Change in left ventricular ejection fraction
Ramy czasowe: 6, 12 and 24 months after mitral edge-to-edge repair
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Echocardiographic assessment of left ventricular ejection fraction measured according to biplane Simpson disk summation method. |
6, 12 and 24 months after mitral edge-to-edge repair
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Christoph MD Gräni, PHD, Department of Cardiology, University Hospital Bern, Inselspital, Bern
Publikacje i pomocne linki
Publikacje ogólne
- Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
- Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
- Praz F, Grasso C, Taramasso M, Baumbach A, Piazza N, Tamburino C, Windecker S, Maisano F, Prendergast B. Mitral regurgitation in heart failure: time for a rethink. Eur Heart J. 2019 Jul 14;40(27):2189-2193. doi: 10.1093/eurheartj/ehz222. No abstract available.
- Grani C, Biere L, Eichhorn C, Kaneko K, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Incremental value of extracellular volume assessment by cardiovascular magnetic resonance imaging in risk stratifying patients with suspected myocarditis. Int J Cardiovasc Imaging. 2019 Jun;35(6):1067-1078. doi: 10.1007/s10554-019-01552-6. Epub 2019 Feb 12.
- Grani C, Eichhorn C, Biere L, Kaneko K, Murthy VL, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Comparison of myocardial fibrosis quantification methods by cardiovascular magnetic resonance imaging for risk stratification of patients with suspected myocarditis. J Cardiovasc Magn Reson. 2019 Feb 28;21(1):14. doi: 10.1186/s12968-019-0520-0.
- Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2021-00704
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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