DNA/RNA Analysis of Blood and Skeletal Muscle in Patients Undergoing Cardiac Resynchronization Therapy (CRT) (Medusa PH)
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|ClinicalTrials.gov Identifier: NCT00600392|
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 20, 2016
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 or disease|
|Cardiomyopathy (Ischemic or Non-Ischemic)|
1. The general objective of this study is to:
- 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
- To identify objective measurable molecular signals, using gene expression profiling, that correlate with clinical improvement in patients undergoing CRT.
- 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.
- To identify biochemical pathways involved in cardiac cachexia.
- To identify genes involved in positive remodeling and reversal of apoptotic cascade in the skeletal muscle.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Transcriptomal Analysis of Peripheral Blood and Skeletal Muscle in Patients Undergoing CRT Using Oligonucleotide Arrays|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2011|
patients who meet criteria for CRT-D implantation
- Shift of the muscle transcriptome away from Apoptosis/Inflammation. Reversal of active apoptosis in skeletal muscle.Quality of life assessment(Minn.HF Ques) Exercise capacity (6 min walk). [ Time Frame: 6 months ]
- Improved LV synchrony as determined by TDI, Decrease in blood markers of inflammation and Oxidative stress and catabolism. [ Time Frame: 6 months ]
Biospecimen Retention: Samples With DNA
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600392
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Patrick Hranitzky, MD||Duke University|