Heart Failure Study: The Atlanta Cardiomyopathy Consortium (TACC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Javed Butler, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00599014
First received: January 11, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Atlanta Cardiomyopathy Consortium

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Death, Heart Transplant, Left Ventricular Assist Device Implantation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood for DNA/RNA/Proteomics analysis and Urine for proteomic analysis


Enrollment: 335
Study Start Date: November 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiology and general medicine clinics; Inpatients from cardiology services

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599014

Locations
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
Investigators
Principal Investigator: Javed Butler, MD, MPH Emory University
  More Information

No publications provided

Responsible Party: Javed Butler, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00599014     History of Changes
Other Study ID Numbers: IRB00005380
Study First Received: January 11, 2008
Results First Received: November 13, 2013
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014