Markers of Oxidative Stress Diastolic Dysfunction (ODDS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Emory University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Emory University
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00846404
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Show Detailed Description
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 |
Resource links provided by NLM:
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
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
More Information
No publications provided
Keywords provided by Emory University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
No publications provided
Responsible Party: | Tai-Hwang Michael Fan, MD, PhD, Atlanta VAMC |
ClinicalTrials.gov Identifier: | NCT00846404 History of Changes |
Other Study ID Numbers: | 730-2006 |
Study First Received: | February 16, 2009 |
Last Updated: | February 17, 2009 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
heart failure cardiomyopathy diastolic dysfunction |
Additional relevant MeSH terms:
Heart Failure Heart Failure, Diastolic Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 26, 2012