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Heart; Disease, Mitral(Valve)Dutch AMRNCT01708265

The Dutch Asymptomatic Mitral Regurgitation Trial

A study testing Watchful waiting and Early mitral valve repair in people with Heart; Disease, Mitral(Valve) and Diseases of Mitral Valve, run by UMC Utrecht at 4 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Watchful waiting and Early mitral valve repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesNetherlands
Study dates
Feb 2013to Feb 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asymptomatic
  • Severe organic mitral valve regurgitation.
  • Preserved left ventricular function (left ventricular ejection fraction >60% and left ventricular end-systolic dimension ≤45 mm)
  • 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
  • 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
  • Moderate to severe kidney disease (eGFR less than 30 mL/min)
  • Flail leaflet together with a left ventricular end systolic diameter (LVESD) >40 mm

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Amsterdam Medisch Centrum

    Amsterdam

  • Amphia Hospital

    Breda

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

  • University Medical Center Utrecht (UMC Utrecht)

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Dutch AMR; Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation; a Multicenter, Randomised Trial.

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

Read the detailed description

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 and 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 [citations 1-3]. 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 it has proven to be eventually associated with good perioperative and postoperative outcome in 50% of the patients at 10 years when careful follow-up is being carried out [citation 4]. Non-randomised trials inherently have a number of drawbacks. A randomised trial comparing both strategies and objectivising the best treatment strategy has never been performed.

The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective, randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients with severe organic MV regurgitation and preserved LV function [citation 5, 6].

Being tested
Watchful waiting, Early mitral valve repair
Keywords
Mitral Valve Insufficiency, Mitral Valve Regurgitation, Asymptomatic Mitral Valve Regurgitation, Asymptomatic Mitral Valve Insufficiency, Mitral Valve Repair, Watchful Waiting
Medical subject headings
Disease, Mitral Valve Insufficiency

What participants receive

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

  • Watchful waitingOther

    In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.

  • Early mitral valve repairProcedure or surgery

    Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.

Study groups in NCT01708265
Study groupRoleWhat they receive
Early mitral valve repairActive comparatorEarly mitral valve repair
Receives: Procedure: Early mitral valve repair
Watchful waitingActive comparatorWatchful waiting
Receives: Other: Watchful waiting

What is being measured

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

  1. Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events

    The primary outcome is defined as 'time to first event'. It concerns time to first event of the composite endpoint of cardiovascular mortality, congestive heart failure, non-fatal cardiovascular events requiring hospitalization, defined as: stroke/cerebrovascular accident (CVA), atrial fibrillation (permanent or requiring hospitalization) and/or reoperation after elective MV surgery.

    Measured: Min. 5 years

Secondary outcomes (15)

  1. Cardiovascular mortality

    Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).

    Measured: Min. 5 years

  2. Congestive heart failure

    Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).

    Measured: Min. 5 years

  3. Hospitalization for nonfatal cardiovascular events

    Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).

    Measured: Min. 5 years

  4. All-cause mortality

    Secondary outcome measures the incidence of all-cause mortality at a minimum of 5 years.

    Measured: Min. 5 years

  5. Costs and effectiveness

    Secondary outcome measures total direct and indirect costs and cost-effectiveness at a minimum of 5 years.

    Measured: Min. 5 years

  6. Health-related quality of life

    Secondary outcome measures health-related quality of life at a minimum of 5 years.

    Measured: Min. 5 years

  7. Echocardiographic parameters

    Secondary outcome measures echocardiographic parameters at a minimum of 5 years.

    Measured: Min. 5 years

  8. CMR parameters

    Secondary outcome measures Cardiovascular Magnetic Resonance imaging (CMR) parameters at a minimum of 5 years.

    Measured: Min. 5 years.

  9. Paroxysmal atrial fibrillation

    Secondary outcome measures the incidence of paroxysmal atrial fibrillation at a minimum of 5 years.

    Measured: Min. 5 years

  10. Exercise test parameters

    Secondary outcome measures exercise test parameters at a minimum of 5 years.

    Measured: Min. 5 years.

  11. BNP

    Secondary outcome measures brain natriuretic peptide (BNP) plasma levels at a minimum of 5 years.

    Measured: Min. 5 years

  12. Myocardial infarction

    Secondary outcome measures the incidence of myocardial infarction at a minimum of 5 years.

    Measured: Min. 5 years

  13. Pacemaker implantation

    Secondary outcome measures the incidence of pacemaker implantation at a minimum of 5 years.

    Measured: Min. 5 years

  14. Transient ischemic attack

    Secondary outcome measures the incidence of transient ischemic attack (TIA) at a minimum of 5 years.

    Measured: Min. 5 years

  15. Pulmonary embolism

    Secondary outcome measures the incidence of pulmonary embolism at a minimum of 5 years.

    Measured: Min. 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 posted16 Oct 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2021 (estimated)
  4. Study completionFeb 2021 (estimated)

Why it stopped: low inclusion rate

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01708265
Sponsor's protocol ID
NL39851.041.12.
Acronym
Dutch AMR
Status last verified
Nov 2016
First submitted
11 Oct 2012
Last updated
23 Nov 2016
Results posted
No
Data monitoring committee
Yes

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

  • Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.

    PubMed 15745978

  • Chenot F, Montant P, Vancraeynest D, Pasquet A, Gerber B, Noirhomme PH, El Khoury G, Vanoverschelde JL. Long-term clinical outcome of mitral valve repair in asymptomatic severe mitral regurgitation. Eur J Cardiothorac Surg. 2009 Sep;36(3):539-45. doi: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.

    PubMed 19632855

  • 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

  • Tietge WJ, de Heer LM, van Hessen MW, Jansen R, Bots ML, van Gilst W, Schalij M, Klautz RJ, Van den Brink RB, Van Herwerden LA, Doevendans PA, Chamuleau SA, Kluin J. Early mitral valve repair versus watchful waiting in patients with severe asymptomatic organic mitral regurgitation; rationale and design of the Dutch AMR trial, a multicenter, randomised trial. Neth Heart J. 2012 Mar;20(3):94-101. doi: 10.1007/s12471-012-0249-y.

    PubMed 22354529

  • Jansen R, Kluin J, Chamuleau SA. Research versus clinical practice in asymptomatic patients with severe organic mitral regurgitation and preserved LV function. J Am Coll Cardiol. 2014 Oct 14;64(15):1639-40. doi: 10.1016/j.jacc.2014.07.964. No abstract available.

    PubMed 25301470

Questions about this trial

What is this clinical trial studying?

A study testing Watchful waiting and Early mitral valve repair in people with Heart; Disease, Mitral(Valve) and Diseases of Mitral Valve, run by UMC Utrecht at 4 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 4 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: stopped early, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study was stopped early (reason given: low inclusion rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events (time frame: Min. 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 NCT01708265, which also lists 6 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 23 Nov 2016.

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