Heart Failure
Conditions
Keywords
Cardiomyopathy, heart failure, DNA,, echocardiography, messenger RNA, natural history
Brief summary
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.
Detailed description
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: 1. Medical history of the patient 2. Medical history on the patient's family 3. Survey data including health behaviors & psychosocial variables 4. Blood & urine samples 5. EKG 6. Six minute Walk Test 7. Hand grip strength 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.
Interventions
None listed
Sponsors
Emory University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 18 years and over * Sex: Both * Ethnic Origin: All * Diagnosis required to participate: Clinical diagnosis of systolic or diastolic heart failure
Exclusion criteria
* Congenital heart disease * Previous heart transplantation * No primary infiltrative disease i.e. amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death, Heart Transplant, Left Ventricular Assist Device Implantation | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization | 30 days |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Heart Failure All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years | 335 |
| Total | 335 |
Baseline characteristics
| Characteristic | Patients With Heart Failure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 35 Participants |
| Age, Categorical Between 18 and 65 years | 300 Participants |
| Age, Continuous | 57.3 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 335 participants |
| Sex: Female, Male Female | 134 Participants |
| Sex: Female, Male Male | 201 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
Death, Heart Transplant, Left Ventricular Assist Device Implantation
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Heart Failure | Death, Heart Transplant, Left Ventricular Assist Device Implantation | 35 participants |
Secondary
Hospitalization
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Heart Failure | Hospitalization | 84 participants |