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Mitral RegurgitationDutch-AMRNCT03975998

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

An observational study of Mitral Regurgitation, run by UMC Utrecht at 6 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Mitral Regurgitation
What is being tested?
Mitral valve repair
Type of treatment
Surgery or procedure
How many people
500 participants
Where
6 sitesNetherlands
Study dates
Oct 2016to Oct 2031
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Asymptomatic patients with severe organic mitral regurgitation and preserved ejection fraction.

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

Netherlands6 sites, 5 recruiting

  • Amsterdam Medical Center (AMC)

    Amsterdam

    Matthijs Boekholdt, s.m.boekholdt@amsterdamumc.nl

    Jolanda Kluin

    Recruiting

  • Amphia Breda

    Breda

    Jeroen Schaap, jschaap@amphia.nl

    Jeroen Schaap, MD

    Recruiting

  • Medisch Spectrum Twente (MST)

    Enschede

    Lodewijk Wagenaar, L.Wagenaar@mst.nl

    Lodewijk Wagenaar

    Recruiting

  • Leiden University Medical Center (LUMC)

    Leiden

    Active, not recruiting

  • Maastricht UMC

    Maastricht

    Bas Streukens, bas.streukens@mumc.nl

    Recruiting

  • University Medical Center Utrecht (UMC Utrecht)

    Utrecht, 3584 CX

    Steven AJ Chamuleau, MD, PhD, 0031 88 75 59801, S.A.J.Chamuleau@umcutrecht.nl

    Steven AJ Chamuleau, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read more

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.

Being tested
Mitral valve repair
Keywords
Mitral regurgitation, Mitral repair, Watchful waiting, Asymptomatic
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitral valve repairProcedure or surgery

    Minimally invasive repair of severe organic mitral regurgiation

Study groups in NCT03975998
Study groupRoleWhat they receive
Aymptomatic patients with severe mitral regurgitationWatchful waiting Early Surgery
Receives: Procedure: Mitral valve repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to event: cardiovascular mortality, congestive heart failure, hospitalization, class I or class IIa indication for MV surgery

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study startOct 2016
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975998
Sponsor's protocol ID
16/743
Acronym
Dutch-AMR
Status last verified
Jun 2019
First submitted
28 Nov 2016
Last updated
6 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ling LH, Enriquez-Sarano M, Seward JB, Orszulak TA, Schaff HV, Bailey KR, Tajik AJ, Frye RL. Early surgery in patients with mitral regurgitation due to flail leaflets: a long-term outcome study. Circulation. 1997 Sep 16;96(6):1819-25. doi: 10.1161/01.cir.96.6.1819.

    PubMed 9323067

  • Rosenhek R, Rader F, Klaar U, Gabriel H, Krejc M, Kalbeck D, Schemper M, Maurer G, Baumgartner H. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation. 2006 May 9;113(18):2238-44. doi: 10.1161/CIRCULATIONAHA.105.599175. Epub 2006 May 1.

    PubMed 16651470

  • Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 2007 Jan;28(2):230-68. doi: 10.1093/eurheartj/ehl428. Epub 2007 Jan 26. No abstract available.

    PubMed 17259184

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation, run by UMC Utrecht at 6 sites in Netherlands.

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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

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?

Time to event: cardiovascular mortality, congestive heart failure, hospitalization, class I or class IIa indication for MV surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975998, which also lists 3 linked publications.

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 6 Jun 2019.

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