Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure

NCT01307722 | Unknown DMC

• 1 other identifier: VGHKS11-CT3-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Purpose- According to our prior studies, left atrial (LA) distensibility was associated significantly with left ventricular filling pressure in patients with acute myocardial infarction (AMI), chronic stable angina, and severe mitral regurgitation. LA distensibility can be used as noninvasive Swan-Ganz catheter. Additionally, it could predict in-hospital mortality in AMI patients. In the current study, left atrial distensibility guiding management in advanced chronic heart failure will be performed to assess whether those management could influence long-term prognosis including mortality rate, rehospitalization rate and the duration of rehospitalization. Materials and Methods- Advanced chronic heart failure (HF) is defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months. Three hundred HF cases will be recruited - 100 with sinus rhythm, and 100 with atrial fibrillation served as LA distensibility guided treatment group (guide group) and another 100 patients, either sinus rhythm or atrial fibrillation, served as control group. The management of guide group will be adjusted by LA distensibility, including the dose of inotropic agents, diuretics, beta-blocker, ACEI, and AIIB. Initially, the guide group will be followed 1 time per 2 week at first 3 months, then 1 time per month later. The control group will be treated by conventional management and traditional echocardiography can be performed as in-charge doctor request. The necessity of hospitalization for heart failure will be adjusted by 2 cardiovascular specialists and all patients admitted for heart failure will be managed by the same one cardiovascular specialist (Shih-Hung Hsiao). The total duration of follow-up will be 2 years. For life-threatening heart failure, intravenous nitroprusside drip under continuous A-line monitor, percutaneous coronary intervention, Swan-Ganz catheter insertion, intra-aortic balloon pump, and ECMO can be done according to the order of in-charge doctor. The primary end-point will be all-cause mortality. The second end-points will be heart failure with hospitalization and the duration of each hospitalization. Additionally, the ratios of medication changes in 2-year follow-up, including diuretics, inotropic agents, beta blockers, ACEI, and AIIB, will be assessed. Analysis will also be performed to estimate the trends of heart function (either systolic or diastolic) and renal function during 2-year follow-up according to whether guiding by LA distensibility is done or not.

Conditions

Chronic Heart Failure

Keywords

left atrial distensibility; advanced chronic heart failure; decompensation; rehospitalization; prognosis; all-cause mortality; heart failure with hospitalization; the duration of hospitalization

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  After LA distensibility-guiding management, patients with decompensated heart failure will be under regular follow-up of events for 2 years. The events include all-cause mortality, heart failure with hospitalization, and the duration of hospitalization.

  2 years

Secondary Outcomes (2)

• heart failure with hospitalization

  2 years

• the duration of hospitalization

  2 years

Study Arms (2)

Patients under LA distensibility-guiding management

EXPERIMENTAL

The management of guide group will be adjusted by LA distensibility, including the adjustments of inotropic agents, diuretics, beta-blocker, ACEI, and AIIB.

Other: left atrial distensibility-guiding prescription of heart failure drugs

patients under conservative monitor and management

NO INTERVENTION

This group will be treated by conventional management and traditional echocardiography can be performed as in-charge doctor request. Renal function will be checked 1 time per 3 months.

Interventions

left atrial distensibility-guiding prescription of heart failure drugs OTHER

This study is a prospective, observational, and open label investigation. The guide group will be followed 1 time per 2 week at first 3 months, then 1 time per month later, and then 1 time per 3 months. Each time, the guide group should receive echocardiography, including the measurement of LA distensibility. LA distensibility-guided therapy is enabled in 2 ways. Prescriptions should be adjusted according to overall left ventricular filling pressure estimated by LA distensibility. The specified treatments after adjustment by the current LA distensibility are also allowed. Investigators individually adjust medications for each patient according to the ranges of LA distensibility. The specified therapy is based on 5 LA distensibility ranges (very low, low, optimal, high, and very high). Each range is associated with a prescription for medication dosing, sodium and fluid intake, or activity level.

Patients under LA distensibility-guiding management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced chronic heart failure (HF) will be defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months.

You may not qualify if:

• presence of mitral stenosis or prosthetic mitral valve
• any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)
• 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, Republic of China, Taiwan, 813, Taiwan

Location

Related Publications (11)

• 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 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

• Giannuzzi P, Temporelli PL, Bosimini E, Silva P, Imparato A, Corra U, Galli M, Giordano A. Independent and incremental prognostic value of Doppler-derived mitral deceleration time of early filling in both symptomatic and asymptomatic patients with left ventricular dysfunction. J Am Coll Cardiol. 1996 Aug;28(2):383-90. doi: 10.1016/0735-1097(96)00163-5.

  PMID: 8800114 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

• Nistri S, Olivotto I, Betocchi S, Losi MA, Valsecchi G, Pinamonti B, Conte MR, Casazza F, Galderisi M, Maron BJ, Cecchi F. Prognostic significance of left atrial size in patients with hypertrophic cardiomyopathy (from the Italian Registry for Hypertrophic Cardiomyopathy). Am J Cardiol. 2006 Oct 1;98(7):960-5. doi: 10.1016/j.amjcard.2006.05.013. Epub 2006 Aug 14.

  PMID: 16996883 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

• Ujino K, Barnes ME, Cha SS, Langins AP, Bailey KR, Seward JB, Tsang TS. Two-dimensional echocardiographic methods for assessment of left atrial volume. Am J Cardiol. 2006 Nov 1;98(9):1185-8. doi: 10.1016/j.amjcard.2006.05.040. Epub 2006 Sep 7.

  PMID: 17056324 BACKGROUND

• Thomas L, Levett K, Boyd A, Leung DY, Schiller NB, Ross DL. Compensatory changes in atrial volumes with normal aging: is atrial enlargement inevitable? J Am Coll Cardiol. 2002 Nov 6;40(9):1630-5. doi: 10.1016/s0735-1097(02)02371-9.

  PMID: 12427416 BACKGROUND

• Hsiao CS, Hsiao SH, Chiou FR, Chiou KR. Early predicting improvement of severe systolic heart failure by left atrial volume. Heart Vessels. 2023 Apr;38(4):523-534. doi: 10.1007/s00380-022-02199-5. Epub 2022 Nov 21.

  PMID: 36409354 DERIVED

• Hsiao SH, Chu KA, Wu CJ, Chiou KR. Left Atrial Expansion Index Predicts Left Ventricular Filling Pressure and Adverse Events in Acute Heart Failure With Severe Left Ventricular Dysfunction. J Card Fail. 2016 Apr;22(4):272-9. doi: 10.1016/j.cardfail.2016.01.009. Epub 2016 Jan 19.

  PMID: 26805452 DERIVED

Study Officials

• Shih-Hung Hsiao, MD

  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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 3, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 3, 2011

Record last verified: 2011-03

Locations

TW (1)