Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
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|ClinicalTrials.gov Identifier: NCT01172184|
Recruitment Status : Completed
First Posted : July 29, 2010
Results First Posted : June 7, 2011
Last Update Posted : June 7, 2011
|Condition or disease||Intervention/treatment|
|Mitral Valve Insufficiency Atrial Fibrillation Heart Failure||Procedure: Cardiac catheterization|
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|Official Title:||Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Severe mitral regurgitation
Patients with severe mitral regurgitation are admitted for pre-operation cardiac catheterization and are willing to participate in this study.
Procedure: Cardiac catheterization
Before surgical intervention for severe mitral regurgitation, cardiac catheterization will be performed and left ventricular filling pressure will be assessed. Simultaneously, echocardiography, including left atrial distensibility, will be performed.
- Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization [ Time Frame: 1 year ]Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.
- Number of Participants With Post-operation Atrial Fibrillation [ Time Frame: baseline and 1 year ]After operation, patients received continuous EKG monitor during the ICU stay. After transfer to ordinary ward, patients received 2 times of EKG record per day and another EKG would be done if patients felt palpitation and irregular heart beats were found by nursing staffs. The event of atrial fibrillation (Af) was defined as irregular irregular heart beats which was lack of p wave and last for more than 30 seconds. The relationship between left atrial distensibility and post-operative Af was analysed. ROC curve was used to assess the best cutoff value of left atrial distensibility.
- Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period [ Time Frame: 1-2 years ]After discharge from index hospitalization of surgical intervention, heart failure with rehospitalization will be assessed. Heart failure with re-hospitalization was documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needed an augmented decongestive regimen during an in-hospital stay. The correlation between left atrial distensibility and heart failure was analyzed. ROC curve was used to estimate the best cut-off point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172184
|Kaohsiung Veterans General Hospital|
|Kaohsiung, Taiwan, 886|
|Study Chair:||Jong-Khing Huang, MD||Department of Medical Education and Research Kaohsiung Veterans General Hospital|