Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes

This study has been terminated.
(No funding, lost support staff. No data collected/processed)
Sponsor:
Information provided by (Responsible Party):
Heather Bloom, Emory University
ClinicalTrials.gov Identifier:
NCT01151553
First received: June 25, 2010
Last updated: September 10, 2013
Last verified: September 2013

June 25, 2010
September 10, 2013
October 2008
March 2010   (final data collection date for primary outcome measure)
Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve
Comparison of Markers of Oxidative Stress PRe and Post Cardiac Resynchronization Therapy as Outcome [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predice which patients who receive CRT will improve
Complete list of historical versions of study NCT01151553 on ClinicalTrials.gov Archive Site
Not Provided
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Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes
Comparative of Markers of Oxidative Stress Present Pre and Post Cardiac Resynchronization Therapy Outcome Predictors

This is a research study that is evaluating blood markers which may predict which patients who receive CRT will improve. Congestive heart failure (CHF) is associated with increased oxidative stress, a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart and cause damage to the heart muscle. We would like to see if blood levels of these forms improve after CRT, and if they can be measured early after surgery to predict who will and who will not benefit from surgery.

Congestive heart failure (CHF) is a common diagnosis with significant clinical impact. Although medical therapy exists, many patients on optimal medical treatment are still highly symptomatic. About 1/3 of these patients have a condition known as "dyssynchrony", where the walls of the heart beat in an uncoordinated way, causing worsening of CHF symptoms. A newer therapy known as cardiac resynchronization therapy (CRT) has been successful in decreasing symptoms in these dyssynchronous patients. It involves surgical placement of a pacemaker containing 3 wires- one in the top part of the heart (atrium) to coordinate the top and bottom parts of the heart beat, and two on the bottom to coordinate the bottom parts of the heart beat (ventricles). This treatment, however, does not work for up to 1/3 of patients with dyssynchrony.

Recent studies have found that CHF is associated with increased oxidative stress. This is a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart, causing them to beat abnormally and causing damage to the heart muscle. We would like to see if levels of these forms improve after CRT, and if they can be measured early after surgery to predict who will and who will not benefit from surgery.

In this study, we will compare blood markers of oxidative stress between patients with CHF and an already-collected set of control patients to confirm these levels are elevated at baseline. Then, we will perform CRT surgery and implant pacemakers in the CHF patients. At 1 week and 3 months postoperatively, we will measure blood markers again, and see if they have improved in patients whose symptoms have improved. Patients will undergo echocardiograms to document their abnormal hearts, do a 6 minute hall walk to measure their exercise tolerance, and take a standardized questionnaire to measure their symptoms of CHF. These test results will be compared pre and post CRT to assess response to therapy.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Device: CRT Therapy
Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk
Patients with CHF with CRT Therapy
Patients with CHF with CRT Therapy
Intervention: Device: CRT Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
July 2011
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Screen for enrollment criteria,
  • Consented,
  • Echocardiogram and electrocardiogram performed,
  • Demographics reviewed,
  • Obtain blood sample,
  • Pre-operative QOL questionnaire.

Exclusion Criteria:

  • 6 minute hall walk.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01151553
IRB00012235
No
Heather Bloom, Emory University
Emory University
Not Provided
Principal Investigator: Heather L Bloom, MD, FACC Emory University IRB
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP