Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure

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

Interventions

OTHER

left atrial distensibility-guiding prescription of heart failure drugs

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.

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• Kaohsiung Veterans General Hospital.

  lead OTHER

Principal Investigators

• Shih-Hung Hsiao, MD · Kaohsiung Veterans General Hospital.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• Taiwan

Study Locations