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Markers of Oxidative Stress Diastolic Dysfunction (ODDS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Emory University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846404
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Emory University
  Purpose

This study is to look at the differences between people who have evidence of abnormal heart relaxation (diastolic dysfunction) on sound wave pictures of the heart (an echocardiogram) compared to those who do not. If you have abnormal relaxation, it can be a cause of shortness of breath or can be present without knowing about it.

A condition known as oxidative stress mayb e associated with this abnormal relaxation. This condition occurs when abnormal oxygen injures heart cells. We would like to learn if patients with abnormal relaxation have increased oxidative stress.


Condition
Diastolic Heart Failure Diastolic Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Markers of Oxidative Stress Present in Blood in Patients With Diastolic Dysfunction

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Evidence of diastolic dysfuntion documented by echocardiography with six months before the time of enrollment. [ Time Frame: Documented six month before the time of enrollment. ]

Secondary Outcome Measures:
  • This study is observational. It entails measurement products from a blood draw. [ Time Frame: One visit that is at enrollment. No follow ups. ]

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Patients with Diastolic Dysfunction
Control
Patients without Diastolic Dysfunction

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of primary care cardiology clinics at Emory University.
Criteria

Inclusion Criteria:

  • Patients age ≥ 18 years.
  • Able to provide informed consent.
  • Cases must have diastolic dysfunction documented by echocardiography an interval of six month before the time of enrollment.

Exclusion Criteria:

  • Control subjects must not have diastolic dysfunction documented by echocardiography in an interval of six month before the time of enrollment.
  • All subjects will be in sinus rhythm.
  • All patients will have a left ventricular ejection fraction of > 55% but less than < 70%.
  • All patients will have normal systolic and diastolic cardiac dimensions on the qualifying echocardiogram.
  Contacts and Locations
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): NCT00846404


Locations
United States, Georgia
Atlanta VAMC
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Tai-Hwang M Fan, MD, PhD Emory Univeristy IRB
  More Information

Responsible Party: Tai-Hwang Michael Fan, MD, PhD, Atlanta VAMC
ClinicalTrials.gov Identifier: NCT00846404     History of Changes
Other Study ID Numbers: 730-2006
First Submitted: February 16, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by Emory University:
heart failure
cardiomyopathy
diastolic dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases