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Sponsored by: |
Duke University |
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00600392 |
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
Condition |
Cardiomyopathy (Ischemic or Non-Ischemic) |
MedlinePlus related topics: | Cardiomyopathy Exercise and Physical Fitness |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Transcriptomal Analysis of Peripheral Blood and Skeletal Muscle in Patients Undergoing CRT Using Oligonucleotide Arrays |
Serum TNF alpha, IL-1, IL6, CRP, uric acid, albumin, BNP, IGF-1 and growth hormone at baseline and at 6 months.
50 ml of blood will be collected at baseline and at 6 months. It will be divided into aliquots as follows; 10 ml in Pax-gene tubes for mRNA extraction, 20 ml for various other biomarkers, 10 ml for proteomics and 10 ml will be stored for any future use.
Approximately a 5x5 - 7x7mm muscle biopsy will be obtained from the mid thigh region of each subject at baseline and at six months
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
1
patients who meet criteria for CRT-D implantation
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1. The general objective of this study is to:
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients who are scheduled for a CRT-D device
Inclusion Criteria:
Exclusion Criteria:
Contact: Margaret Stewart, RN | 919-668-3524 | stewa070@mc.duke.edu |
United States, North Carolina | |||||
Duke University Medical Center | Recruiting | ||||
Durham, North Carolina, United States, 27710 | |||||
Contact: Margaret Stewart, RN 919-668-3524 stewa070@mc.duke.edu | |||||
Principal Investigator: Patrick Hranitzky, MD |
Duke University |
Principal Investigator: | Patrick Hranitzky, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Patrick Hranitzky, MD ) |
Study ID Numbers: | 00009277 / 7523, Not applicable to our study |
First Received: | January 15, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00600392 |
Health Authority: | United States: Institutional Review Board |
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