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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 15, 2008

Last Updated Date

August 15, 2008

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600392 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Improved LV synchrony as determined by TDI, Decrease in blood markers of inflammation and Oxidative stress and catabolism. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Detailed Description

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 Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Cardiomyopathy (Ischemic or Non-Ischemic)

Intervention ^†

Study Arms / Comparison Groups

patients who meet criteria for CRT-D implantation

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Margaret Stewart, RN

919-668-3524

stewa070@mc.duke.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600392

Responsible Party

Patrick Hranitzky, MD, Duke University Medical Center

Secondary IDs ^††

Not applicable to our study

Study Sponsor ^†

Duke University

Collaborators ^††

Investigators ^†

Principal Investigator:

Patrick Hranitzky, MD

Duke University

Information Provided By

Duke University

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.