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Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation (Dutch-AMR)

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ClinicalTrials.gov Identifier: NCT03975998
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
Netherlands Heart Institute
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amphia Hospital
Maastricht University Medical Center
Medisch Spectrum Twente
Leiden University Medical Center
Information provided by (Responsible Party):
S.A.J. Chamuleau, UMC Utrecht

Brief Summary:

Rationale:

Severe asymptomatic organic Mitral Valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst American guidelines are more in favour of early surgery to reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future LV dysfunction and complaints.

A number of non-randomised trials show a favourable outcome of early surgery: in the study of Enriquez-Sarano et al. for instance, the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality, and decreased morbidity compared with the conservative management [1]. On the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is performed in this population (50% at 10 years follow-up according to Rosenhek et al [2]), it has proven to be eventually associated with good perioperative and postoperative outcome when careful follow-up is being carried out [2].

Objective:

To compare early MV repair versus watchful waiting in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

Study design:

Multicenter, registry trial.

Study population:

250 Asymptomatic patients (18-75 years old) with severe organic MV regurgitation and preserved left ventricular function. The current European Society of Cardiology (ESC) guidelines on Valvular Heart Disease will be applied [3]. These guidelines are also used in the Netherlands. Accordingly, patients with an indication for MV surgery will not be included.

Intervention:

Intervention will be early MV repair compared to a watchful waiting strategy.


Condition or disease Intervention/treatment
Mitral Regurgitation Procedure: Mitral valve repair

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Dutch-AMR Study: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation and Preserved Ejection Fraction: a Multicenter Registry Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2031

Group/Cohort Intervention/treatment
Aymptomatic patients with severe mitral regurgitation
Watchful waiting Early Surgery
Procedure: Mitral valve repair
Minimally invasive repair of severe organic mitral regurgiation




Primary Outcome Measures :
  1. Time to event: cardiovascular mortality, congestive heart failure, hospitalization, class I or class IIa indication for MV surgery [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic patients with severe organic mitral regurgitation and preserved ejection fraction.
Criteria

Inclusion Criteria:

  • 18-75 years.
  • Asymptomatic patients. "Asymptomatic" is defined as absence of subjective limitations of exercise capacity or complaints expressed by the patient and confirmed by the treating cardiologist.
  • Severe organic mitral valve regurgitation. "Severe organic mitral valve regurgitation" is defined as non-ischemic mitral valve regurgitation with an organic cause (intrinsic valve lesion) as determined by echocardiographic core-lab reading based on the criteria for definition of severe MR as issued by the ESC guidelines [4]. For practical reasons, referring cardiologists can use an ESC guidelines based index that was validated in the investigator's core-lab (Jansen et al, Practical echocardiographic semi-quantitative scoring system to determine severity of mitral regurgitation. Abstract presentation at ESC EUROECHO Congress 2011 and annual spring congress 2012 Netherlands Society of Cardiology).
  • Preserved left ventricular function, "Preserved left ventricular function" is defined as left ventricular ejection fraction >60% and left ventricular end-systolic dimension <45 mm (no indexed value, measured by echocardiography).
  • The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon.

Exclusion Criteria:

  • Pulmonary hypertension (>50 mmHg at rest).
  • Atrial fibrillation, either on 12-lead ECG or holter-monitoring.
  • Physical inability as determined by the heart team to undergo surgery.
  • Other life-threatening morbidity.
  • Higher expected surgical risks in advance, according to the dedicated heart team.
  • Patients with moderate to severe kidney disease (estimated glomerular filtration rate (eGFR) less than 30 mL/min).
  • Flail leaflet together with a left ventricular end systolic diameter (LVESD) ≥40 mm (no indexed value)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975998


Locations
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Netherlands
Amsterdam Medical Center (AMC) Recruiting
Amsterdam, Netherlands
Contact: Matthijs Boekholdt       s.m.boekholdt@amsterdamumc.nl   
Sub-Investigator: Jolanda Kluin         
Principal Investigator: Matthijs Boekholdt         
Sub-Investigator: Rene van den Brink         
Amphia Breda Recruiting
Breda, Netherlands
Contact: Jeroen Schaap       jschaap@amphia.nl   
Principal Investigator: Jeroen Schaap, MD         
Medisch Spectrum Twente (MST) Recruiting
Enschede, Netherlands
Contact: Lodewijk Wagenaar       L.Wagenaar@mst.nl   
Principal Investigator: Lodewijk Wagenaar         
Leiden University Medical Center (LUMC) Active, not recruiting
Leiden, Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands
Contact: Bas Streukens       bas.streukens@mumc.nl   
University Medical Center Utrecht (UMC Utrecht) Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Steven AJ Chamuleau, MD, PhD    0031 88 75 59801    S.A.J.Chamuleau@umcutrecht.nl   
Principal Investigator: Steven AJ Chamuleau, MD, PhD         
Sub-Investigator: Einar A Hart, MD         
Sub-Investigator: Maarten Jan M Cramer, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Netherlands Heart Institute
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amphia Hospital
Maastricht University Medical Center
Medisch Spectrum Twente
Leiden University Medical Center

Publications:
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Responsible Party: S.A.J. Chamuleau, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT03975998     History of Changes
Other Study ID Numbers: 16/743
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by S.A.J. Chamuleau, UMC Utrecht:
Mitral regurgitation
Mitral repair
Watchful waiting
Asymptomatic

Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases