Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function. Thus, the LA volume provides a long-term view of whether the patient has diastolic dysfunction, regardless of the loading conditions present at the examination, such as hemoglobin A1c in diabetes mellitus. To date, the relation between the LA volume and left ventricular (LV) filling pressure has not been confirmed directly by simultaneous echocardiographic catheterization. The present study, therefore, assessed the correlation between the LA volume and LV filling pressure in patients with severe mitral regurgitation (MR). Because the LA pressure increases to maintain adequate LV diastolic filling, increased atrial wall tension tends to dilate the chamber and stretch the atrial myocardium. Therefore, the lower the ability of the left atrium to stretch, the greater the pressure in the left atrium. The study is designed to assess 1) the relationship between LV filling pressure and LA distensibility, and 2) the power of left atrial distensibility to predict the prognosis, including operation mortality, the rate of post-operation atrial fibrillation, and late heart failure event in patients with severe mitral regurgitation.
| Condition | Intervention |
|---|---|
|
Mitral Valve Insufficiency Atrial Fibrillation Heart Failure |
Procedure: Cardiac catheterization |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation |
- Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 111 |
| Study Start Date: | July 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study.
Inclusion Criteria:
- Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study.
Exclusion Criteria:
- Presence of mitral stenosis
- More than mild severity of aortic valvular problem
- Any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)
- Rhythm other than sinus rhythm
- Inadequate image quality
- Lack of informed consent
Contacts and Locations| Taiwan | |
| Kaohsiung Veterans General Hospital | |
| Kaohsiung, Taiwan, 886 | |
| Study Chair: | Jong-Khing Huang, MD | Department of Medical Education and Research Kaohsiung Veterans General Hospital |
More Information
Additional Information:
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 |
Keywords provided by Kaohsiung Veterans General Hospital.:
|
Left atrial distensibility Left ventricular filling pressure Severe mitral regurgitation Prognosis Post-operation (mitral valve replacement or valvuloplasty) atrial fibrillation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Heart Failure Mitral Valve Insufficiency Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Heart Valve Diseases |
ClinicalTrials.gov processed this record on June 18, 2013