Clinical trial NCT00599014: Heart Failure Study: The Atlanta Cardiomyopathy Consortium
Official title: The Atlanta Cardiomyopathy Consortium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Cardiomyopathy, heart failure, DNA,
echocardiography, messenger RNA, natural history
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology and general medicine clinics; Inpatients from cardiology services

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death, Heart Transplant, Left Ventricular Assist Device Implantation
timeFrame: 5 years
Secondary outcomes:
measure: Hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Heart Failure at EUH Midtown, 4th Floor, 550 Peachtree Street
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE
state: Georgia
Study officials:
affiliation: Emory University
name: Javed Butler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: