DNA/RNA Analysis of Blood and Skeletal Muscle in Patients Undergoing Cardiac Resynchronization Therapy (CRT)

NCT ID: NCT00600392

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-12-31

Brief Summary

Genes expressing inflammatory cytokines (TNF- alpha, IL1 etc) and genes involved in apoptosis (Caspase 3, Bax, Bcl-2, Fas) are dysregulated in the skeletal muscles of the patients who have muscle wasting and decreased exercise capacity with CHF.

Patients who show benefit from CRT may also show reversal of the inflammatory/apoptotic cascade that accompanies CHF and these patients may be the ones who benefit the most from CRT

Detailed Description

1. The general objective of this study is to:

1. To identify the molecular pathways that may be altered in the blood and skeletal muscles of the patients undergoing CRT by using transcriptional analysis of the blood and skeletal muscle in these patients

2. To identify objective measurable molecular signals, using gene expression profiling, that correlate with clinical improvement in patients undergoing CRT.

3. To identify the molecular profile of patients who are most likely to benefit from CRT with improvement of exercise capacity and reversal of cardiac cachexia.

4. To identify biochemical pathways involved in cardiac cachexia.

5. To identify genes involved in positive remodeling and reversal of apoptotic cascade in the skeletal muscle.

Conditions

Cardiomyopathy (Ischemic or Non-Ischemic)

Study Design

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

Study Groups

1

patients who meet criteria for CRT-D implantation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with poor LV function and an EF of ≤35%
• Patients who are symptomatic with Class II or Class III heart failure on optimal medical therapy.
• Patients with EKG showing QRS duration of greater than 120 ms and meet criteria for Bi-ventricular ICD implantation.

Exclusion Criteria

• Patients with other co-morbid conditions which could contribute to cachexia, such as end stage renal disease, ongoing malignancy, chronic or acute liver failure, age greater than 80yrs.
• Patients who are unable to walk and are wheelchair bound or need assistance to walk for reasons other than CHF.
• Patients with muscular dystrophies and myopathies.
• Patients with untreated hyper or hypothyroidism.
• Patients on Dialysis.
• Patients with recent (<12 weeks) revascularization.
• Patients with recent (<12 weeks) myocardial infarction.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Hranitzky, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

7523

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00009277

Identifier Type: -

Identifier Source: org_study_id