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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00953953 |
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Date of registration:
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05/08/2009 |
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Primary sponsor: |
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Public title:
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Study of Left Ventricular Dyssynchrony in Heart Failure Patients
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Scientific title:
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Study of the Phenomenon of Dynamic Left Ventricular Dyssynchrony in Heart Failure Patients and Its Clinical Significance. |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00953953 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Darshak Karia, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Albert Einstein Healthcare Network |
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Key inclusion & exclusion criteria
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ACUTELY DECOMPENSATED SYSTOLIC HEART FAILURE
Inclusion Criteria:
- Patients over the age of 18 and able to consent
- NYHA Class III or IV
- EF= 35%
- Diagnosis of acute congestive heart failure exacerbation by history or physical
examination
- Ability to understand and willing to sign informed consent
- Willingness to follow-up for clinic visits at 30 days and 6 months
Exclusion Criteria:
- Pacemaker
- Patients requiring and willing to sign informed consent
- Unwillingness to provide consent
CHRONIC HEART FAILURE on DIALYSIS GROUP
Inclusion Criteria:
- Patients over the age of 18 and able to consent
- NYHA Class II, III, or IV
- EF = 35% with a screening echocardiogram
- Ability to understand and willing to sign informed consent
- Willingness to follow up at 30 days and 6 months via phone contact
Exclusion Criteria:
- Unwillingness to provide consent
- Pacemaker
AMBULATORY CHRONIC HEART FAILURE GROUP
Inclusion Criteria:
- Patients over the age of 18 and able to consent
- NYHA Class II and III with an EF = 35%
- Diagnosis of chronic heart failure and currently on optimal medical therapy,
including ACE, or ARB, beta-blockers and diuretics including spironolactone
- Ability to understand and willing to sign informed consent
- Willingness to follow up as an outpatient at 30 days and 6 months
Exclusion Criteria:
- Incapable of taking the 6-minute walk test due to any condition unrelated to heart
failure
- Patients requiring chronic inotrope therapy
- Pacemaker
- Symptoms of angina limiting exercise ability
- Unwillingness to provide consent
ACUTELY DECOMPENSATED DIASTOLIC HEART FAILURE GROUP
Inclusion Criteria:
- Patients over the age of 18 and able to consent
- NYHA Class III or IV
- EF = 45%
- Diagnosis of acute congestive heart failure exacerbation by history or physical
examination
- Ability to understand and willing to sign informed consent
- Willingness to follow-up for clinic visits at 30 days and 6 months
Exclusion Criteria:
- Pacemaker
- Patients requiring inotrope support on admission
- Unwillingness to provide consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Device: Phillips ultrasound system
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Primary Outcome(s)
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Acutely Decompensated Diastolic Heart Failure Group: Assess the incidence of change in dyssynchrony at admission and prior to discharge during acutely decompensated diastolic heart failure exacerbation hospitalization
[Time Frame: 6 months]
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Acutely Decompensated Systolic HF Group:Assess the incidence of change in dyssynchrony at admission and prior to discharge during acute decompensated heart failure exacerbation hospitalization
[Time Frame: 6 months]
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Ambulatory Chronic Heart Failure Patients Group: Assess the incidence of change in dyssynchrony at rest and during peak exercise in Chronic Heart failure patients.
[Time Frame: 6 months]
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Chronic Heart Failure on Dialysis Group: Assess the incidence of change in dyssynchrony before, during, and after dialysis
[Time Frame: 6 months]
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Secondary Outcome(s)
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All four arms: Determine the change of dyssynchrony
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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