Mitral Valve InsufficiencyNCT00806988

Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation

A study testing Mitral Valve Repair and CABG in people with Mitral Valve Insufficiency and Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 27 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Mitral Valve Insufficiency, Coronary Artery Disease
What is being tested?: Mitral Valve Repair and CABG
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 27 sitesin 3 countries
Study dates: Dec 2008to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO between 0.2 cmsq to 0.39 cmsq. If ERO < 0.2, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
CAD that is amenable to CABG and a clinical indication for revascularization
Age ≥ 18 years

Who cannot join

Any evidence of structural (chordal or leaflet) mitral valve disease
Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
Planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [PFO] or atrial septal defect [ASD]or Maze procedure or left atrial appendage excision)
Prior surgical or percutaneous mitral valve repair
Contraindication to cardiopulmonary bypass (CPB)
Clinical signs of cardiogenic shock at the time of surgery

Show all 15Show fewer

Treatment with chronic intravenous inotropic therapy at the time of surgery
Severe, irreversible pulmonary hypertension in the judgment of the investigator
ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
Congenital heart disease (except PFO or ASD)
Evidence of cirrhosis or liver synthetic failure
Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator
Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in the study
Any concurrent disease with a life expectancy of less than 2 years
Pregnancy at the time of randomization

Trial locations and contacts

27 sites in 3 countries.

Country

City, postcode or hospital

27 sites in 3 countries

United States19 sites

Mission Hospital
Asheville, North Carolina, 28801
Emory University
Atlanta, Georgia, 30383
University of Maryland
Baltimore, Maryland, 21201
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, 20892
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
East Carolina Heart Institute
Greenville, North Carolina, 27834
University of Southern California
Los Angeles, California, 90033
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Baylor Research Institute
Plano, Texas, 75093
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University
St Louis, Missouri, 63110
Montefiore Einstein Heart Center
The Bronx, New York, 10467

Other trials in United States

Canada7 sites

University of Alberta Hospital
Edmonton, Alberta, T6G2B7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, QC H4J 1C5
Quebec Heart Institute/Laval Hopital
Québec, Quebec, H7M 3L9
University of Toronto Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8
University of Toronto, Toronto General Hospital
Toronto, Ontario, M5G 2C4

Other trials in Canada

Denmark1 site

Aarhus University Hospital
Aarhus N, 8200

Other trials in Denmark

About this study

Official title: Surgical Interventions for Moderate Ischemic Mitral Regurgitation

Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart. During a CABG procedure, people who have a leak in one of the valves in the heart-the mitral valve-may at the same time undergo a procedure that repairs the valve. This study will evaluate whether people with moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve repair procedure or undergoing CABG alone.

Read the detailed description

CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. CABG is one treatment option for people with CAD. During a CABG procedure, a healthy artery or vein from another part of the body is connected to the blocked coronary artery. Blood flow is then routed around the blockage to the heart.

After a heart attack, some people may have a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR) and is associated with poor health outcomes, including worsening heart failure. In people with severe mitral valve leakage, the CABG procedure and a mitral valve repair procedure are routinely performed together; however, in people with only moderate valve leakage, there is no consensus in the medical community as to whether the mitral valve repair procedure is beneficial at the time of CABG. The purpose of this study is to determine whether people with moderate mitral valve regurgitation should undergo a mitral valve repair procedure in addition to CABG or undergo CABG alone.

This study will enroll people with CAD who require a CABG procedure and have moderate mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either CABG surgery and the mitral valve repair procedure or only CABG surgery. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.

Conditions: Mitral Valve Insufficiency, Coronary Artery Disease
Being tested: Mitral Valve Repair, CABG
Keywords: Ischemic Mitral Regurgitation, Mitral Valve Regurgitation
Medical subject headings: Mitral Valve Insufficiency, Coronary Artery Disease

What participants receive

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

Mitral Valve RepairProcedure or surgery
Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABGProcedure or surgery
CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.

Study groups in NCT00806988
Study group	Role	What they receive
Mitral Valve Repair	Active comparator	Participants will undergo CABG and a mitral valve repair procedure. Receives: Procedure: Mitral Valve Repair; Procedure: CABG
CABG	Active comparator	Participants will undergo CABG. Receives: Procedure: CABG

What is being measured

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

Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Measured: Measured at Month 12

Secondary outcomes (1)

Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention
Measured: Measured at Month 24

Timeline

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

Dec 2008May 2015

First posted11 Dec 2008 (estimated)
Study startDec 2008
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00806988
Sponsor's protocol ID: GCO 08-1078-00003
Other IDs: U01HL088942, 594
Status last verified: Apr 2017
First submitted: 10 Dec 2008
Last updated: 26 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Smith PK, Puskas JD, Ascheim DD, Voisine P, Gelijns AC, Moskowitz AJ, Hung JW, Parides MK, Ailawadi G, Perrault LP, Acker MA, Argenziano M, Thourani V, Gammie JS, Miller MA, Page P, Overbey JR, Bagiella E, Dagenais F, Blackstone EH, Kron IL, Goldstein DJ, Rose EA, Moquete EG, Jeffries N, Gardner TJ, O'Gara PT, Alexander JH, Michler RE; Cardiothoracic Surgical Trials Network Investigators. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2014 Dec 4;371(23):2178-88. doi: 10.1056/NEJMoa1410490. Epub 2014 Nov 18.
PubMed 25405390
Bertrand PB, Overbey JR, Zeng X, Levine RA, Ailawadi G, Acker MA, Smith PK, Thourani VH, Bagiella E, Miller MA, Gupta L, Mack MJ, Gillinov AM, Giustino G, Moskowitz AJ, Gelijns AC, Bowdish ME, O'Gara PT, Gammie JS, Hung J; Cardiothoracic Surgical Trials Network (CTSN). Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation. J Am Coll Cardiol. 2021 Feb 16;77(6):713-724. doi: 10.1016/j.jacc.2020.11.066.
PubMed 33573741
Capoulade R, Zeng X, Overbey JR, Ailawadi G, Alexander JH, Ascheim D, Bowdish M, Gelijns AC, Grayburn P, Kron IL, Levine RA, Mack MJ, Melnitchouk S, Michler RE, Mullen JC, O'Gara P, Parides MK, Smith P, Voisine P, Hung J; Cardiothoracic Surgical Trials Network (CTSN) Investigators. Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty. Circulation. 2016 Oct 25;134(17):1247-1256. doi: 10.1161/CIRCULATIONAHA.115.021014.
PubMed 27777294
Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ Jr, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3.
PubMed 27040451

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
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Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
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Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
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All Mitral Valve Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surgical Interventions for Moderate Ischemic Mitral Regurgitation
ClinicalTrials.gov ID: NCT00806988
Acronym / sponsor ID: GCO 08-1078-00003
Conditions: Mitral Valve Insufficiency, Coronary Artery Disease
Keywords: Ischemic Mitral Regurgitation, Mitral Valve Regurgitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Dec 2008
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 11 Dec 2008 (estimated)
Results: Posted 26 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mitral Valve Repair	Active comparator	Procedure: Mitral Valve Repair, Procedure: CABGParticipants will undergo CABG and a mitral valve repair procedure.
CABG	Active comparator	Procedure: CABGParticipants will undergo CABG.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO between 0.2 cmsq to 0.39 cmsq. If ERO < 0.2, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
CAD that is amenable to CABG and a clinical indication for revascularization
Age ≥ 18 years

Key exclusion criteria (15 listed)

Any evidence of structural (chordal or leaflet) mitral valve disease
Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
Planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [PFO] or atrial septal defect [ASD]or Maze procedure or left atrial appendage excision)
Prior surgical or percutaneous mitral valve repair
Contraindication to cardiopulmonary bypass (CPB)

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
Mitral Valve RepairSurgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: 1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. 2. The heart will be arrested with cardioplegia. 3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.	Procedure or surgery	Mitral Valve Repair
CABGCABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.	Procedure or surgery	CABG, Mitral Valve Repair

Primary outcome

Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Time frame: Measured at Month 12

1 secondary outcome

Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention
Time frame: Measured at Month 24

Results and safety

Results posted to the registry on 26 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mitral Valve Repair	150	123
CABG	151	108

Primary outcome: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)

Time frame: Measured at Month 12. Mean (Standard Deviation). Unit: ml per square meter

Measure	Mitral Valve Repair n = 150	CABG n = 151
Value	49.6 (31.5)	46.1 (22.4)

Mitral Valve Repair vs CABG: p = 0.61, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mitral Valve Repair	88 of 150 (58.7%)	44 of 150 (29.3%)	15 of 150
CABG	79 of 151 (52.3%)	37 of 151 (24.5%)	16 of 151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25405390Smith PK, Puskas JD, Ascheim DD, Voisine P, Gelijns AC, Moskowitz AJ, Hung JW, Parides MK, Ailawadi G, Perrault LP, Acker MA, Argenziano M, Thourani V, Gammie JS, Miller MA, Page P, Overbey JR, Bagiella E, Dagenais F, Blackstone EH, Kron IL, Goldstein DJ, Rose EA, Moquete EG, Jeffries N, Gardner TJ, O'Gara PT, Alexander JH, Michler RE; Cardiothoracic Surgical Trials Network Investigators. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2014 Dec 4;371(23):2178-88. doi: 10.1056/NEJMoa1410490. Epub 2014 Nov 18.
Derived from this study: PubMed 33573741Bertrand PB, Overbey JR, Zeng X, Levine RA, Ailawadi G, Acker MA, Smith PK, Thourani VH, Bagiella E, Miller MA, Gupta L, Mack MJ, Gillinov AM, Giustino G, Moskowitz AJ, Gelijns AC, Bowdish ME, O'Gara PT, Gammie JS, Hung J; Cardiothoracic Surgical Trials Network (CTSN). Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation. J Am Coll Cardiol. 2021 Feb 16;77(6):713-724. doi: 10.1016/j.jacc.2020.11.066.
Derived from this study: PubMed 27777294Capoulade R, Zeng X, Overbey JR, Ailawadi G, Alexander JH, Ascheim D, Bowdish M, Gelijns AC, Grayburn P, Kron IL, Levine RA, Mack MJ, Melnitchouk S, Michler RE, Mullen JC, O'Gara P, Parides MK, Smith P, Voisine P, Hung J; Cardiothoracic Surgical Trials Network (CTSN) Investigators. Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty. Circulation. 2016 Oct 25;134(17):1247-1256. doi: 10.1161/CIRCULATIONAHA.115.021014.
Derived from this study: PubMed 27040451Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ Jr, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3.
Click here for the Cardiothoracic Surgical Trials Network Web site.Link provided by the sponsor.

Related trials for Mitral Valve Insufficiency

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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.

Timothy Gardner, MD study chair

Christiana Care Health Services

Patrick O'Gara, MD study chair

Brigham and Women's Hospital

Annetine Gelijns, Ph.D. principal investigator

Icahn School of Medicine at Mount Sinai

27 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mitral Valve Repair and CABG in people with Mitral Valve Insufficiency and Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 27 sites in 3 countries.

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 3 inclusion and 15 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: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada, Denmark. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) (time frame: Measured at Month 12). 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 NCT00806988, which also lists 4 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 26 Jun 2017.