Markers of Oxidative Stress Diastolic Dysfunction

NCT00846404 | Unknown

• 1 other identifier: 730-2006
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diastolic Heart Failure; Diastolic Dysfunction

Keywords

heart failure; cardiomyopathy; diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Evidence of diastolic dysfuntion documented by echocardiography with six months before the time of enrollment.

  Documented six month before the time of enrollment.

Secondary Outcomes (1)

• This study is observational. It entails measurement products from a blood draw.

  One visit that is at enrollment. No follow ups.

Study Arms (2)

Case

Patients with Diastolic Dysfunction

Control

Patients without Diastolic Dysfunction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of primary care cardiology clinics at Emory University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Atlanta VAMC

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tai-Hwang M Fan, MD, PhD

  Emory Univeristy IRB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: July 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: July 1, 2010
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

US (1)