NCT00608140|TerminatedPhase 3ResultsDMC
Loading search results
Unable to recruit sufficient numbers of patients.
SMMART-HF
Surgery Versus Medical Treatment Alone for Patients With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure: SMMART-HF
Sponsor study identifier
Secondary identifiers
NIH
interventional
2
2 countries
9
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the heart. Improper functioning of the mitral valve disrupts the proper flow of blood through the body, resulting in shortness of breath and fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR may be associated with serious complications, such as heart failure, irregular heart rhythm, and high blood pressure. Although there are treatments for MR, including medication and surgery, more information is needed on the effectiveness of these treatments in people with significant MR. This study will compare the safety and effectiveness of corrective surgery added to optimal medical treatment (OMT) versus OMT alone in treating people with significant MR caused by an enlarged heart.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 24, 2008
Actual (reported)February 6, 2008
Actual (reported)March 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 2010
Actual (reported)March 2010
Actual (reported)July 18, 2013
Actual (reported)Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)
Measured at Month 18
Peak VO2
Measured at Month 18
Change in 6-minute Walk Test
Measured at baseline and Month 18 but n/a
Change in Minnesota Living With Heart Failure (MLHF) Score
Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
Participants will receive optimal medical therapy alone
Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement
Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Minnesota Heart Failure Network
Minneapolis, Minnesota, 55415, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah Health Sciences Center
Murray, Utah, 84107, United States
Kerry L. Lee, PhD
Duke Clinical Research Institute
Eugene Braunwald, MD
Harvard University
2 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2008
First Posted
February 6, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Planned to be measured at baseline and Month 18 but n/a
Total Days Alive and Total Days Not Hospitalized
Measured at baseline and Month 18
Total Mortality (All Causes)
Measured at Month 18
Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University of Vermont - Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Montreal Heart Institute
Montreal, Quebec, H1T - 1C8, Canada
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)Last Updated
April 4, 2018
Results First Posted
July 18, 2013
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: