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Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01172184
First received: July 28, 2010
Last updated: May 9, 2011
Last verified: June 2010
History of Changes
Results First Received: March 3, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Mitral Valve Insufficiency
Atrial Fibrillation
Heart Failure
Intervention: Procedure: Cardiac catheterization

  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
The present study enrolled 111 patients with severe mitral regurgitation (MR) who had undergone cardiac catheterization in Kaohsiung veterans general hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients With Either Chronic or Acute Mitral Regurgitation No text entered.

Participant Flow:   Overall Study
    Patients With Either Chronic or Acute Mitral Regurgitation  
STARTED     111  
COMPLETED     111  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Patients With Either Chronic or Acute Mitral Regurgitation No text entered.

Baseline Measures
    Patients With Either Chronic or Acute Mitral Regurgitation  
Number of Participants  
[units: participants]
 		  111  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     61  
>=65 years     50  
Age  
[units: years]
Mean ± Standard Deviation 		  68  ± 18  
Gender  
[units: participants]
 		 
Female     56  
Male     55  
Region of Enrollment  
[units: participants]
 		 
Taiwan     111  



  Outcome Measures
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1.  Primary:   Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Post-operation Atrial Fibrillation   [ Time Frame: baseline and 1 year ]
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3.  Secondary:   Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period   [ Time Frame: 1-2 years ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
LV filling pressure was obtained using fluid-filled pigtail catheters.Although micromanometer-tipped catheters would have been ideal, the method we used to measure LV filling pressure is standard in the clinical setting and is well validated.  


Results Point of Contact:  
Name/Title: Dr. Shih-Hung Hsiao
Organization: Kaohsiung veterans general hospital
phone: 886-7-3422121 ext 1518
e-mail: irb@vghks.gov.tw


Publications of Results:

Other Publications:


Responsible Party: Jong-Khing Huang, MD, Current Superintendent of Kaohsiung Veterans General Hospital, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01172184     History of Changes
Other Study ID Numbers: NSC99-2314-B-075B-007, VGHKS99-CT7-06
Study First Received: July 28, 2010
Results First Received: March 3, 2011
Last Updated: May 9, 2011
Health Authority: Taiwan: Department of Health