Clinical trial NCT01151553: Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes
Official title: Comparative of Markers of Oxidative Stress Present Pre and Post Cardiac Resynchronization Therapy Outcome Predictors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Cardiology
Cardiomyopathy
Cardiovascular Disease
Cardiac Resynchronization Therapy (CRT)
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University IRB
name: Heather L Bloom, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: