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

Cardiomyopathy (Ischemic or Non-Ischemic) Clinical Trial

— Medusa PH  

Official title:

Transcriptomal Analysis of Peripheral Blood and Skeletal Muscle in Patients Undergoing CRT Using Oligonucleotide Arrays

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600392
• Other study ID #: Pro00009277
• Secondary ID: 7523
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 15, 2016
• Start date: January 2006
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy (Ischemic or Non-Ischemic)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 months	No
Secondary	Improved LV synchrony as determined by TDI, Decrease in blood markers of inflammation and Oxidative stress and catabolism.		6 months	No