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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
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 25, 2010
    Last Updated
    September 10, 2013
    Sponsor
    Emory University
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    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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