Heart Failure Study: The Atlanta Cardiomyopathy Consortium (TACC)

October 4, 2015 updated by: Javed Butler, MD, Emory University

The Atlanta Cardiomyopathy Consortium

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Center for Heart Failure at EUH Midtown, 4th Floor, 550 Peachtree Street
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiology and general medicine clinics; Inpatients from cardiology services

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death, Heart Transplant, Left Ventricular Assist Device Implantation
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospitalization
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Javed Butler, MD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00005380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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