Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes
Primary Purpose
Congestive Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CRT Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Cardiology, Cardiomyopathy, Cardiovascular Disease, Cardiac Resynchronization Therapy (CRT)
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with CHF with CRT Therapy
Arm Description
Patients with CHF with CRT Therapy
Outcomes
Primary Outcome Measures
Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151553
Brief Title
Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes
Official Title
Comparative of Markers of Oxidative Stress Present Pre and Post Cardiac Resynchronization Therapy Outcome Predictors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
No funding, lost support staff. No data collected/processed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Cardiology, Cardiomyopathy, Cardiovascular Disease, Cardiac Resynchronization Therapy (CRT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with CHF with CRT Therapy
Arm Type
Other
Arm Description
Patients with CHF with CRT Therapy
Intervention Type
Device
Intervention Name(s)
CRT Therapy
Intervention Description
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 Measure Information:
Title
Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome
Description
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
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather L Bloom, MD, FACC
Organizational Affiliation
Emory University IRB
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes
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