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
  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

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Population

Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172184

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 886
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
National Science Council, Taiwan
Investigators
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:
Heart Failure
Atrial Fibrillation
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 19, 2014