Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes

NCT01151553 | Terminated Results

• 1 other identifier: IRB00012235
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a research study that is evaluating blood markers which may predict which patients who receive CRT will improve. Congestive heart failure (CHF) is associated with increased oxidative stress, a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart and cause damage to the heart muscle. We would like to see if blood levels of these forms improve after CRT, and if they can be measured early after surgery to predict who will and who will not benefit from surgery.

Conditions

Congestive Heart Failure

Keywords

Cardiology; Cardiomyopathy; Cardiovascular Disease; Cardiac Resynchronization Therapy (CRT)

Outcome Measures

Primary Outcomes (1)

• Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome

  Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve

  One year

Study Arms (1)

Patients with CHF with CRT Therapy

OTHER

Patients with CHF with CRT Therapy

Device: CRT Therapy

Interventions

CRT Therapy DEVICE

Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk

Patients with CHF with CRT Therapy

Eligibility Criteria

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

You may qualify if:

• Screen for enrollment criteria,
• Consented,
• Echocardiogram and electrocardiogram performed,
• Demographics reviewed,
• Obtain blood sample,
• Pre-operative QOL questionnaire.

You may not qualify if:

• minute hall walk.

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.

Results Point of Contact

• Title: Dr. Heather Bloom
• Organization: Emory University

heather.bloom@emory.edu

404-321-6111

Study Officials

• Heather L Bloom, MD, FACC

  Emory University IRB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2011
• Last Updated: September 19, 2013
• Results First Posted: August 14, 2013

Record last verified: 2013-09