Heart Failure Study: The Atlanta Cardiomyopathy Consortium

NCT ID: NCT00599014

Last Updated: 2015-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Javed Butler, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Javed Butler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Center for Heart Failure at EUH Midtown, 4th Floor, 550 Peachtree Street

Atlanta, Georgia, United States

Site Status

The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00005380

Identifier Type: -

Identifier Source: org_study_id

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