Study of Left Ventricular Dyssynchrony in Heart Failure Patients

Completed

• Conditions: Heart Failure
• Interventions: Device: Phillips ultrasound system

• Registration Number: NCT00953953
• Lead Sponsor: Albert Einstein Healthcare Network

Brief Summary

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. Patient with Heart Failure are prone to have "dyssynchrony" which means that there are electrical disturbances that cause the heart to pump blood in an inefficient way. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure. Based on these observations, techniques have been developed to correct dyssynchrony. The investigators propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. The investigators 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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acutely Decompensated Systolic HF	Phillips ultrasound system	Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).
Chronic HF Patients on Dialysis	Phillips ultrasound system	Patients who have heart failure (defined as NYHA class II, III, or IV) and are on dialysis.
Ambulary Chronic HF	Phillips ultrasound system	Patients with diagnosis of chronic heart failure (NYHA class II and III) who are on optimal medical therapy.
Acutely Decompensated Diastolic HF	Phillips ultrasound system	Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).

Primary Outcome Measures

Name	Time	Method
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	6 months
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	6 months
Chronic Heart Failure on Dialysis Group: Assess the incidence of change in dyssynchrony before, during, and after dialysis	6 months
Ambulatory Chronic Heart Failure Patients Group: Assess the incidence of change in dyssynchrony at rest and during peak exercise in Chronic Heart failure patients.	6 months

Secondary Outcome Measures

Name	Time	Method
All four arms: Determine the change of dyssynchrony	6 months

Trial Locations

Locations (1)

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States