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Heart failure is a very common cause of hospital admission and there are half a million new cases diagnosed each year in the United States. While some important progress has been made over the last two decades for the treatment of heart failure, there still remains a critical need for further advances in our understanding of this disease in order to significantly improve patient outcomes. Large numbers of heart failure patients need to be studied over time to allow scientists to investigate those factors that influence the responses to therapy.
In this study information will be collected on patients with heart failure and their progress and outcomes will be followed over time. The aim is to understand the natural history, risk factors for improvement or progression, and determinants of response to therapy for heart failure. Of interest are many aspects of heart failure including genetic influences, quality of life issues, how individuals cope with feelings about having heart disease, and how they manage their day-to-day symptoms etc.. A database will be created of approximately 1,000 heart failure patients from Emory, Emory University Hospital Midtown, Wesley Woods, Grady, and the VA Medical Center.
This is strictly an observational study and subjects will not be receiving any experimental therapy nor will their routine medical care be affected in any way. Data to be collected includes:
After collecting data, a variety of statistical tests will be run to analyze factors that influence heart failure patients' responses to treatment. The results of this analysis will be used to optimize therapy for future heart failure patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Death, Heart Transplant, Left Ventricular Assist Device Implantation | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiology and general medicine clinics; Inpatients from cardiology services
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| Name | Affiliation | Role |
|---|---|---|
| Javed Butler, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Heart Failure at EUH Midtown, 4th Floor, 550 Peachtree Street | Atlanta | Georgia | 30308 | United States | ||
All patients willing to participate to the study were enrolled. Because this was an observational study, no patients with heart failure (ischemic and non-ischemic) were excluded from participation. Only patients with congenital and infiltrated etiologies were not eligible for the study.
All participants were stable patients with heart failure. They were recruited during one of their visits to heart failure clinics. The recruitment period started in November 2007 until December 2010. This was an observational study with no interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Heart Failure | All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Heart Failure | All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Death, Heart Transplant, Left Ventricular Assist Device Implantation | Posted | Number | participants | 5 years |
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Adverse Events were not collected or observed as part of this observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Heart Failure | All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years |
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Long baseline visit with several questionnaires to be completed made more difficult for the patients to be enrolled. Adverse Events data was not collected as part of this observational registry.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Javed Butler | Emory University | 404-778-5136 | jbutle4@emory.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Blood for DNA/RNA/Proteomics analysis and Urine for proteomic analysis
| The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Hospitalization | Posted | Number | participants | 30 days |
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| 0 |
| 0 |
| 0 |
| 0 |
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