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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
Information provided by:
Emory University Identifier:
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009

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.

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)
Patients with Diastolic Dysfunction
Patients without Diastolic Dysfunction

  Show Detailed Description


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00846404

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

Responsible Party: Tai-Hwang Michael Fan, MD, PhD, Atlanta VAMC Identifier: NCT00846404     History of Changes
Other Study ID Numbers: 730-2006
Study First Received: February 16, 2009
Last Updated: February 17, 2009

Keywords provided by Emory University:
heart failure
diastolic dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases processed this record on September 19, 2017