Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes

Emory University

Status: Terminated

Conditions: Congestive Heart Failure

Treatments: Device: CRT Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01151553

IRB00012235

Details and patient eligibility

About

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.

Full description

Congestive heart failure (CHF) is a common diagnosis with significant clinical impact. Although medical therapy exists, many patients on optimal medical treatment are still highly symptomatic. About 1/3 of these patients have a condition known as "dyssynchrony", where the walls of the heart beat in an uncoordinated way, causing worsening of CHF symptoms. A newer therapy known as cardiac resynchronization therapy (CRT) has been successful in decreasing symptoms in these dyssynchronous patients. It involves surgical placement of a pacemaker containing 3 wires- one in the top part of the heart (atrium) to coordinate the top and bottom parts of the heart beat, and two on the bottom to coordinate the bottom parts of the heart beat (ventricles). This treatment, however, does not work for up to 1/3 of patients with dyssynchrony.

Recent studies have found that CHF is associated with increased oxidative stress. This is a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart, causing them to beat abnormally and causing damage to the heart muscle. We would like to see if 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.

In this study, we will compare blood markers of oxidative stress between patients with CHF and an already-collected set of control patients to confirm these levels are elevated at baseline. Then, we will perform CRT surgery and implant pacemakers in the CHF patients. At 1 week and 3 months postoperatively, we will measure blood markers again, and see if they have improved in patients whose symptoms have improved. Patients will undergo echocardiograms to document their abnormal hearts, do a 6 minute hall walk to measure their exercise tolerance, and take a standardized questionnaire to measure their symptoms of CHF. These test results will be compared pre and post CRT to assess response to therapy.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 6 minute hall walk.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Patients with CHF with CRT Therapy

Other group

Description:

Patients with CHF with CRT Therapy

Treatment:

Device: CRT Therapy