- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953953
Study of Left Ventricular Dyssynchrony in Heart Failure Patients
Study of the Phenomenon of Dynamic Left Ventricular Dyssynchrony in Heart Failure Patients and Its Clinical Significance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Heart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. It has been noted that 15% of all HF patients and 30% of those with NYHA class III and IV HF have intraventricular conduction delay, with a QRS duration >120 ms, most commonly manifested as LBBB. These electrical disturbances result in LV dyssynchrony, seen as a paradoxical septal wall motion activity, suboptimal ventricular filling and mitral regurgitation; thus further compromising an already dysfunctioning left ventricle. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure.
Based on these observations, techniques have been developed to correct dyssynchrony. Cardiac resynchronization therapy (CRT) has been shown to improve subjective and objective parameters in heart failure patients with QRS duration > 120msec. However, there is a group of heart failure patients who did not respond to CRT. Also it has been noted that approximately 30% of heart failure patients with QRS duration > 120 msec do not have actual mechanical dyssynchrony by tissue doppler imaging. The electromechanical discrepancy of ventricular dyssynchrony has been suggested as the possible explanation for the lack of response. Also, there are heart failure patients with normal QRS duration who do have mechanical dyssynchrony. These findings bring more emphasis to the importance of mechanical dyssynchrony than electrical dyssynchrony, which is measured by QRS duration on surface EKG.
There are many different modalities to quantify mechanical dyssynchrony. The most commonly used method is tissue doppler imaging (TDI). TDI measures the velocities of myocardial tissue and time to maximal velocities. Then, these are used to describe contractions of different wall segments. Strain and strain rates are more sophisticated ways to measure active segment contraction rather than passive movements.
We propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. We also propose to examine dyssynchrony in the setting of acutely decompensated heart failure. The change in dyssynchrony will be followed to examine if it translates into clinical significance.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Acutely Decompensated Systolic HF group: patients who are admitted to Albert Einstein Medical Center on the HF service.
Chronic HF on Dialysis group: patients at the dialysis center at Albert Einstein Medical Center.
Ambulatory Chronic HF group: patients who present to the Albert Einstein Medical Center HF clinic.
Acutely Decompensated Diastolic HF group: patients who are admitted to Albert Einstein Medical Center on the HF service.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acutely Decompensated Systolic HF
Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).
|
The tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle.
|
Chronic HF Patients on Dialysis
Patients who have heart failure (defined as NYHA class II, III, or IV) and are on dialysis.
|
The tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle.
|
Ambulary Chronic HF
Patients with diagnosis of chronic heart failure (NYHA class II and III) who are on optimal medical therapy.
|
The tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle.
|
Acutely Decompensated Diastolic HF
Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).
|
The tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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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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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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6 months
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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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6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All four arms: Determine the change of dyssynchrony
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Darshak Karia, MD, Albert Einstein Healthcare Network
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN 3052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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