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

NCT00600392 | Completed

• 2 other identifiers: Pro000092777523
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiomyopathy (Ischemic or Non-Ischemic)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Improved LV synchrony as determined by TDI, Decrease in blood markers of inflammation and Oxidative stress and catabolism.

  6 months

Study Arms (1)

1

patients who meet criteria for CRT-D implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for a CRT-D device

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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

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

MeSH Terms

Conditions

Cardiomyopathies; Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Hranitzky, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 25, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2011
• Last Updated: January 20, 2016

Record last verified: 2012-11

Locations

US (1)