Heart Failure Study: The Atlanta Cardiomyopathy Consortium

Heart Failure Clinical Trial

— TACC  

Official title:

The Atlanta Cardiomyopathy Consortium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599014
• Other study ID #: IRB00005380
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: October 4, 2015
• Start date: November 2007
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, Heart Transplant, Left Ventricular Assist Device Implantation		5 years	No
Secondary	Hospitalization		30 days	No