Study of Left Ventricular Dyssynchrony in Heart Failure Patients

NCT00953953 | Completed

• 1 other identifier: HN 3052
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (1)

• All four arms: Determine the change of dyssynchrony

  6 months

Study Arms (4)

Acutely Decompensated Systolic HF

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

Device: Phillips ultrasound system

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

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

Acutely Decompensated Diastolic HF

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

Device: Phillips ultrasound system

Interventions

Phillips ultrasound system 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; Acutely Decompensated Systolic HF; Ambulary Chronic HF; Chronic HF Patients on Dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pacemaker
• Patients requiring and willing to sign informed consent
• Unwillingness to provide consent
• CHRONIC HEART FAILURE on DIALYSIS GROUP
• 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
• Unwillingness to provide consent
• Pacemaker
• AMBULATORY CHRONIC HEART FAILURE GROUP
• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Darshak Karia, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Heart Failure Services

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: January 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

US (1)