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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)

This study has been terminated.
(Unable to recruit sufficient numbers of patients.)
Sponsor:
Collaborators:
Heart Failure Clinical Research Network
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00608140
First received: January 24, 2008
Last updated: July 9, 2014
Last verified: July 2013
Results First Received: April 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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
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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
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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.
No text entered.

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  
Number of Participants  
[units: participants]
  1     1     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     1     1  
>=65 years     1     0     1  
Age [1]
[units: years]
Mean ± Standard Deviation
  65.5     63     64.25  ± 1.49  
Gender  
[units: participants]
     
Female     0     1     1  
Male     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     1     1     2  
[1] Standard deviation for individual arms could not be calculated because only 1 participant was evaluated in each arm. Total SD was calculated.



  Outcome Measures
  Show All 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:   Perioperative Mortality   [ Time Frame: Measured between Days 0 and 30 postsurgery ]

3.  Secondary:   Peak VO2   [ Time Frame: Measured at Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in 6-minute Walk Test   [ Time Frame: Measured at baseline and Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Minnesota Living With Heart Failure (MLHF) Score   [ Time Frame: Measured at baseline and Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Total Days Alive and Total Days Not Hospitalized   [ Time Frame: Measured at baseline and Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Total Mortality (All Causes)   [ Time Frame: Measured at Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Kathy Moore
Organization: Duke University
phone: 919-668-8065
e-mail: kathy.moore@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00608140     History of Changes
Other Study ID Numbers: Pro00002860, U01HL084904, U01 HL084904, 520
Study First Received: January 24, 2008
Results First Received: April 29, 2013
Last Updated: July 9, 2014
Health Authority: United States: Federal Government