Congestive Heart Failure
Conditions
Keywords
Cardiology, Cardiomyopathy, Cardiovascular Disease, Cardiac Resynchronization Therapy (CRT)
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.
Interventions
DEVICECRT Therapy
Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome | One year | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With CHF With CRT Therapy Patients with CHF with CRT Therapy
CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Patients With CHF With CRT Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 62.8 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Time frame: One year
Population: Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.