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

NCT01172184 | Completed Results DMC

• 2 other identifiers: NSC99-2314-B-075B-007VGHKS99-CT7-06
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mitral Valve Insufficiency; Atrial Fibrillation; Heart Failure

Keywords

Left atrial distensibility; Left ventricular filling pressure; Severe mitral regurgitation; Prognosis; Post-operation (mitral valve replacement or valvuloplasty) atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization

  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.

  1 year

Secondary Outcomes (2)

• Number of Participants With Post-operation Atrial Fibrillation

  baseline and 1 year

• Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period

  1-2 years

Study Arms (1)

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

Interventions

Cardiac catheterization PROCEDURE

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.

Severe mitral regurgitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 886, Taiwan

Location

Related Publications (7)

• Moller JE, Hillis GS, Oh JK, Seward JB, Reeder GS, Wright RS, Park SW, Bailey KR, Pellikka PA. Left atrial volume: a powerful predictor of survival after acute myocardial infarction. Circulation. 2003 May 6;107(17):2207-12. doi: 10.1161/01.CIR.0000066318.21784.43. Epub 2003 Apr 14.

  PMID: 12695291 BACKGROUND

• Beinart R, Boyko V, Schwammenthal E, Kuperstein R, Sagie A, Hod H, Matetzky S, Behar S, Eldar M, Feinberg MS. Long-term prognostic significance of left atrial volume in acute myocardial infarction. J Am Coll Cardiol. 2004 Jul 21;44(2):327-34. doi: 10.1016/j.jacc.2004.03.062.

  PMID: 15261927 BACKGROUND

• Meris A, Amigoni M, Uno H, Thune JJ, Verma A, Kober L, Bourgoun M, McMurray JJ, Velazquez EJ, Maggioni AP, Ghali J, Arnold JM, Zelenkofske S, Pfeffer MA, Solomon SD. Left atrial remodelling in patients with myocardial infarction complicated by heart failure, left ventricular dysfunction, or both: the VALIANT Echo study. Eur Heart J. 2009 Jan;30(1):56-65. doi: 10.1093/eurheartj/ehn499. Epub 2008 Nov 11.

  PMID: 19001474 BACKGROUND

• Reed D, Abbott RD, Smucker ML, Kaul S. Prediction of outcome after mitral valve replacement in patients with symptomatic chronic mitral regurgitation. The importance of left atrial size. Circulation. 1991 Jul;84(1):23-34. doi: 10.1161/01.cir.84.1.23.

  PMID: 2060099 BACKGROUND

• Chen CG, Thomas JD, Anconina J, Harrigan P, Mueller L, Picard MH, Levine RA, Weyman AE. Impact of impinging wall jet on color Doppler quantification of mitral regurgitation. Circulation. 1991 Aug;84(2):712-20. doi: 10.1161/01.cir.84.2.712.

  PMID: 1860216 BACKGROUND

• Agricola E, Galderisi M, Oppizzi M, Melisurgo G, Airoldi F, Margonato A. Doppler tissue imaging: a reliable method for estimation of left ventricular filling pressure in patients with mitral regurgitation. Am Heart J. 2005 Sep;150(3):610-5. doi: 10.1016/j.ahj.2004.10.046.

  PMID: 16169349 BACKGROUND

• Hsiao SH, Huang WC, Lin KL, Chiou KR, Kuo FY, Lin SK, Cheng CC. Left atrial distensibility and left ventricular filling pressure in acute versus chronic severe mitral regurgitation. Am J Cardiol. 2010 Mar 1;105(5):709-15. doi: 10.1016/j.amjcard.2009.10.052.

  PMID: 20185021 RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency; Atrial Fibrillation; Heart Failure

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Limitations and Caveats

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

• Title: Dr. Shih-Hung Hsiao
• Organization: Kaohsiung veterans general hospital

irb@vghks.gov.tw

886-7-3422121

Study Officials

• Jong-Khing Huang, MD

  Department of Medical Education and Research Kaohsiung Veterans General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 7, 2011
• Results First Posted: June 7, 2011

Record last verified: 2010-06

Locations

TW (1)