Study of Left Ventricular Dyssynchrony in Heart Failure Patients

NCT ID: NCT00953953

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Acutely Decompensated Systolic HF

Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).

Phillips ultrasound system

Intervention Type: DEVICE

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.

Phillips ultrasound system

Intervention Type: DEVICE

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.

Phillips ultrasound system

Intervention Type: DEVICE

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).

Phillips ultrasound system

Intervention Type: DEVICE

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.

Interventions

Phillips ultrasound system

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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

• 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 and willing to sign informed consent
• Unwillingness to provide consent

CHRONIC HEART FAILURE on DIALYSIS GROUP

• Unwillingness to provide consent
• Pacemaker

AMBULATORY CHRONIC HEART FAILURE GROUP

• 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

• Pacemaker
• Patients requiring inotrope support on admission
• Unwillingness to provide consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Darshak Karia, MD

Director, Heart Failure Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darshak Karia, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HN 3052

Identifier Type: -

Identifier Source: org_study_id