Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2011 by Kaohsiung Veterans General Hospital.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01307722
First received: March 2, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention
Chronic Heart Failure
Other: left atrial distensibility-guiding prescription of heart failure drugs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • heart failure with hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. presence of mitral stenosis or prosthetic mitral valve
  2. any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)
  3. inadequate image quality
  4. lack of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307722

Contacts
Contact: Jong-Khing Huang, MD 886-7-3422121 ext 1518 irb@vghks.gov.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Not yet recruiting
Kaohsiung, Taiwan, Republic of China, Taiwan, 813
Contact: Jong-Khing Huang, MD    886-7-3422121 ext 1518    irb@vghks.gov.tw   
Principal Investigator: Shih-Hung Hsiao, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
National Science Council, Taiwan
Investigators
Principal Investigator: Shih-Hung Hsiao, MD Kaohsiung Veterans General Hospital.
  More Information

Additional Information:
Publications:

Responsible Party: Jong-Khing Huang, MD/Current Superinterdent of Kaohsiung Veterans General Hospital, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01307722     History of Changes
Other Study ID Numbers: VGHKS11-CT3-02
Study First Received: March 2, 2011
Last Updated: March 2, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
left atrial distensibility
advanced chronic heart failure
decompensation
rehospitalization
prognosis
all-cause mortality
heart failure with hospitalization
the duration of hospitalization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014