Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure
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|ClinicalTrials.gov Identifier: NCT01307722|
Recruitment Status : Unknown
Verified March 2011 by Kaohsiung Veterans General Hospital..
Recruitment status was: Not yet recruiting
First Posted : March 3, 2011
Last Update Posted : March 3, 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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Other: left atrial distensibility-guiding prescription of heart failure drugs||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
Experimental: Patients under LA distensibility-guiding management
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
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.
No Intervention: patients under conservative monitor and management
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.
- all-cause mortality [ Time Frame: 2 years ]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.
- heart failure with hospitalization [ Time Frame: 2 years ]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.
- the duration of hospitalization [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307722
|Contact: Jong-Khing Huang, MD||886-7-3422121 ext email@example.com|
|Kaohsiung Veterans General Hospital||Not yet recruiting|
|Kaohsiung, Taiwan, Republic of China, Taiwan, 813|
|Contact: Jong-Khing Huang, MD 886-7-3422121 ext 1518 firstname.lastname@example.org|
|Principal Investigator: Shih-Hung Hsiao, MD|
|Principal Investigator:||Shih-Hung Hsiao, MD||Kaohsiung Veterans General Hospital.|