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Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure (SMMART-HF)

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ClinicalTrials.gov Identifier: NCT00608140
Recruitment Status : Terminated (Unable to recruit sufficient numbers of patients.)
First Posted : February 6, 2008
Results First Posted : July 18, 2013
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Heart Failure Clinical Research Network
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Mitral Valve Insufficiency
Heart Failure
Interventions: Procedure: Surgical mitral valvuloplasty with placement of annular ring (SMVR)
Drug: Optimal medical therapy (OMT)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1 Medical Therapy Plus Surgery Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
2 Medical Therapy Only Participants will receive optimal medical therapy alone

Participant Flow:   Overall Study
    1 Medical Therapy Plus Surgery   2 Medical Therapy Only
STARTED   1   1 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   1   1 
[1] Study ended early due to low enrollment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
1 Medical Therapy Plus Surgical Repair Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
2 Medical Therapy Only Participants will receive optimal medical therapy alone
Total Total of all reporting groups

Baseline Measures
   1 Medical Therapy Plus Surgical Repair   2 Medical Therapy Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      1 100.0%      1  50.0% 
>=65 years      1 100.0%      0   0.0%      1  50.0% 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 65.5   63   64.25  (1.49) 
[1] Standard deviation for individual arms could not be calculated because only 1 participant was evaluated in each arm. Total SD was calculated.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1 100.0%      1  50.0% 
Male      1 100.0%      0   0.0%      1  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 


  Outcome Measures

1.  Primary:   Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)   [ Time Frame: Measured at Month 18 ]

2.  Secondary:   Peak VO2   [ Time Frame: Measured at Month 18 ]

3.  Secondary:   Change in 6-minute Walk Test   [ Time Frame: Measured at baseline and Month 18 but n/a ]

4.  Secondary:   Change in Minnesota Living With Heart Failure (MLHF) Score   [ Time Frame: Planned to be measured at baseline and Month 18 but n/a ]

5.  Secondary:   Total Days Alive and Total Days Not Hospitalized   [ Time Frame: Measured at baseline and Month 18 ]

6.  Secondary:   Total Mortality (All Causes)   [ Time Frame: Measured at Month 18 ]

7.  Secondary:   Perioperative Mortality   [ Time Frame: Measured between Days 0 and 30 postsurgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary Ann Sellers
Organization: Duke University
phone: 919-668-8544
e-mail: maryann.sellers@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00608140     History of Changes
Other Study ID Numbers: Pro00002860
U01HL084904 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2008
First Posted: February 6, 2008
Results First Submitted: April 29, 2013
Results First Posted: July 18, 2013
Last Update Posted: April 4, 2018