Heart Failure Study: The Atlanta Cardiomyopathy Consortium (TACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599014
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : January 1, 2014
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Javed Butler, MD, Emory University

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.

Condition or disease
Heart Failure

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.

Study Type : Observational
Actual Enrollment : 335 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Atlanta Cardiomyopathy Consortium
Study Start Date : November 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Death, Heart Transplant, Left Ventricular Assist Device Implantation [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA
Blood for DNA/RNA/Proteomics analysis and Urine for proteomic analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiology and general medicine clinics; Inpatients from cardiology services

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599014

United States, Georgia
Center for Heart Failure at EUH Midtown, 4th Floor, 550 Peachtree Street
Atlanta, Georgia, United States, 30308
The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Javed Butler, MD, MPH Emory University

Responsible Party: Javed Butler, MD, Professor of Medicine, Emory University Identifier: NCT00599014     History of Changes
Other Study ID Numbers: IRB00005380
First Posted: January 23, 2008    Key Record Dates
Results First Posted: January 1, 2014
Last Update Posted: November 2, 2015
Last Verified: August 2015

Keywords provided by Javed Butler, MD, Emory University:
Cardiomyopathy, heart failure, DNA,
echocardiography, messenger RNA, natural history

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases