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Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes

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ClinicalTrials.gov Identifier: NCT01151553
Recruitment Status : Terminated (No funding, lost support staff. No data collected/processed)
First Posted : June 28, 2010
Results First Posted : August 14, 2013
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Heather Bloom, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment
Congestive Heart Failure Device: CRT Therapy

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative of Markers of Oxidative Stress Present Pre and Post Cardiac Resynchronization Therapy Outcome Predictors
Study Start Date : October 2008
Primary Completion Date : March 2010
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Patients with CHF with CRT Therapy
Patients with CHF with CRT Therapy
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



Primary Outcome Measures :
  1. Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome [ Time Frame: One year ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT01151553


Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Heather L Bloom, MD, FACC Emory University IRB

Responsible Party: Heather Bloom, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01151553     History of Changes
Other Study ID Numbers: IRB00012235
First Posted: June 28, 2010    Key Record Dates
Results First Posted: August 14, 2013
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Heather Bloom, Emory University:
Cardiology
Cardiomyopathy
Cardiovascular Disease
Cardiac Resynchronization Therapy (CRT)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases