Category
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Primary study
Registry of Trials»clinicaltrials.gov
Year
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2011
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.
Epistemonikos ID: 0d1b71fc97dbf7b42cb2f2b1d935089e6e6d0e4c
First added on: May 06, 2024