Study of Left Ventricular Dyssynchrony in Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Darshak Karia, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT00953953
First received: August 5, 2009
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Heart Failure
Device: Phillips ultrasound system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Phenomenon of Dynamic Left Ventricular Dyssynchrony in Heart Failure Patients and Its Clinical Significance.

Resource links provided by NLM:


Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Chronic Heart Failure on Dialysis Group: Assess the incidence of change in dyssynchrony before, during, and after dialysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All four arms: Determine the change of dyssynchrony [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acutely Decompensated Systolic HF
Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).
Device: 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.
Chronic HF Patients on Dialysis
Patients who have heart failure (defined as NYHA class II, III, or IV) and are on dialysis.
Device: 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.
Ambulary Chronic HF
Patients with diagnosis of chronic heart failure (NYHA class II and III) who are on optimal medical therapy.
Device: 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.
Acutely Decompensated Diastolic HF
Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV).
Device: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

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
  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: NCT00953953

Locations
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Darshak Karia, MD Albert Einstein Healthcare Network
  More Information

No publications provided

Responsible Party: Darshak Karia, MD, Director, Heart Failure Services, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT00953953     History of Changes
Other Study ID Numbers: HN 3052
Study First Received: August 5, 2009
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014