Left Atrial Distensibility to Predict Prognosis in Consecutive Patients

NCT01171040 | Unknown DMC

• 1 other identifier: VGHKS99-015
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However, myocardial tissue Doppler only provides the information of regional myocardium, so patients with regional wall motion abnormality, as coronary artery disease, can't be assessed by this method without handicap. In addition, conduction disturbance, like bundle branch block, also influences the result of myocardial tissue Doppler. For resolving those problems, the investigators had designed a new global parameter to assess LVFP. In the investigators prior study, left atrial distensibility correlated logarithmically to LVFP in patients with severe mitral regurgitation and also in patients with acute myocardial infarction. Left atrial distensibility provided a new viewpoint to assess left ventricular diastolic function and to predict prognosis. This time, to extend left atrial distensibility to general population received echocardiographic examination for predicting prognosis is attempted.

Conditions

Heart Failure; Atrial Fibrillation; Stroke

Keywords

left atrial distensibility; mortality; heart failure; atrial fibrillation; stroke; prognosis

Outcome Measures

Primary Outcomes (2)

• All cause mortality

  All cause mortality and heart failure with re-hospitalization were defined as hard cardiovascular event.

  2 years

• Heart failure with hospitalization

  Heart failure with re-hospitalization is 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 needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay.

  2 years

Secondary Outcomes (2)

• Atrial fibrillation

  2 years

• Stroke

  2 years

Study Arms (1)

Consecutive patients received echocardiographic examinations

Consecutive patients received echocardiography are willing to participate in this study.

Other: Echocardiography, including the measurements of left atrial (LA) distensibility

Interventions

Echocardiography, including the measurements of left atrial (LA) distensibility OTHER

The LA volumes were measured at three points: 1) immediately before the mitral valve opening (maximal LV volume or Volmax); 2) at onset of the P-wave on electrocardiography (pre-atrial contraction volume or Volp); and 3) at mitral valve closure (minimal LV volume or Volmin). The LA distensibility was calculated as (Volmax - Volmin)x 100% / Volmin. The LA ejection fraction was calculated as (Volp - Volmin)x 100% / Volp. In all patients, LA volumes were indexed to body surface area (BSA).

Consecutive patients received echocardiographic examinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients received echocardiographic examinations

You may qualify if:

• consecutive patients received echocardiographic examination are willing to participate in this study.

You may not qualify if:

• (1) patients with prosthetic mitral valves, or mitral stenosis
• (2) rhythm other than sinus rhythm
• (3) age less than 18 years-old
• (4) inadequate image quality
• (5) lack of informed consent

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 886, Taiwan

RECRUITING

Related Publications (11)

• Kasner M, Westermann D, Steendijk P, Gaub R, Wilkenshoff U, Weitmann K, Hoffmann W, Poller W, Schultheiss HP, Pauschinger M, Tschope C. Utility of Doppler echocardiography and tissue Doppler imaging in the estimation of diastolic function in heart failure with normal ejection fraction: a comparative Doppler-conductance catheterization study. Circulation. 2007 Aug 7;116(6):637-47. doi: 10.1161/CIRCULATIONAHA.106.661983. Epub 2007 Jul 23.

  PMID: 17646587 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

• Appleton CP, Galloway JM, Gonzalez MS, Gaballa M, Basnight MA. Estimation of left ventricular filling pressures using two-dimensional and Doppler echocardiography in adult patients with cardiac disease. Additional value of analyzing left atrial size, left atrial ejection fraction and the difference in duration of pulmonary venous and mitral flow velocity at atrial contraction. J Am Coll Cardiol. 1993 Dec;22(7):1972-82. doi: 10.1016/0735-1097(93)90787-2.

  PMID: 8245357 BACKGROUND

• Rossi A, Cicoira M, Zanolla L, Sandrini R, Golia G, Zardini P, Enriquez-Sarano M. Determinants and prognostic value of left atrial volume in patients with dilated cardiomyopathy. J Am Coll Cardiol. 2002 Oct 16;40(8):1425. doi: 10.1016/s0735-1097(02)02305-7.

  PMID: 12392832 BACKGROUND

• Simek CL, Feldman MD, Haber HL, Wu CC, Jayaweera AR, Kaul S. Relationship between left ventricular wall thickness and left atrial size: comparison with other measures of diastolic function. J Am Soc Echocardiogr. 1995 Jan-Feb;8(1):37-47. doi: 10.1016/s0894-7317(05)80356-6.

  PMID: 7710749 BACKGROUND

• 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

• 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

• Hsiao SH, Chiou KR. Renal function decline predicted by left atrial expansion index in non-diabetic cohort with preserved systolic heart function. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(5):521-528. doi: 10.1093/ehjci/jew224.

  PMID: 28064152 DERIVED

• Hsiao SH, Chiou KR. Left atrial expansion index predicts atrial fibrillation in dyspnea. Circ J. 2013;77(11):2712-21. doi: 10.1253/circj.cj-13-0463. Epub 2013 Jul 26.

  PMID: 23892385 DERIVED

• Hsiao SH, Chiou KR. Left atrial expansion index predicts all-cause mortality and heart failure admissions in dyspnoea. Eur J Heart Fail. 2013 Nov;15(11):1245-52. doi: 10.1093/eurjhf/hft087. Epub 2013 May 22.

  PMID: 23703107 DERIVED

Related Links

• Government Research Bulletin

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Shih-Hung Hsiao, MD

  Cardiovascular Center, Department of Internal Medicine, Kaohsiung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Khing Huang, MD

CONTACT

886-7-3422121; irb@vghks.gov.tw

Study Design

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

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: March 8, 2011

Record last verified: 2009-07

Locations

TW (1)