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

Completed

Conditions studied: Cardiomyopathy (Ischemic or Non-Ischemic)

In brief

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

Key facts

Study ID

NCT00600392

Run by

Duke University

People needed

30

Starts

2006-01-01

Expected to finish

2011-12-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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