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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
Results First Received: July 24, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Intervention: Device: CRT Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients With CHF With CRT Therapy

Patients with CHF with CRT Therapy

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


Participant Flow:   Overall Study
    Patients With CHF With CRT Therapy  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patients With CHF With CRT Therapy

Patients with CHF with CRT Therapy

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


Baseline Measures
    Patients With CHF With CRT Therapy  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  62.8  ± 10.9  
Gender  
[units: participants]
 
Female     0  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Heather Bloom
Organization: Emory University
phone: 404-321-6111 ext 6391
e-mail: heather.bloom@emory.edu


No publications provided


Responsible Party: Heather Bloom, Emory University
ClinicalTrials.gov Identifier: NCT01151553     History of Changes
Other Study ID Numbers: IRB00012235
Study First Received: June 25, 2010
Results First Received: July 24, 2013
Last Updated: September 10, 2013
Health Authority: United States: Institutional Review Board