Heart FailureTACCNCT00599014
Heart Failure Study: The Atlanta Cardiomyopathy Consortium
An observational study of Heart Failure, run by Emory University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 335 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology and general medicine clinics; Inpatients from cardiology services
Who may be able to join
- Age: 18 years and over
- Sex: Both
- Ethnic Origin: All
- Diagnosis required to participate: Clinical diagnosis of systolic or diastolic heart failure
Who cannot join
- Congenital heart disease
- Previous heart transplantation
- No primary infiltrative disease i.e. amyloidosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Heart Failure at EUH Midtown, 4th Floor, 550 Peachtree Street
Atlanta, Georgia, 30308
The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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:
- Medical history of the patient
- Medical history on the patient's family
- Survey data including health behaviors \& psychosocial variables
- Blood \& urine samples
- EKG
- Six minute Walk Test
- 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
- Heart Failure
- Keywords
- Cardiomyopathy, heart failure, DNA,, echocardiography, messenger RNA, natural history
- Medical subject headings
- Heart Failure, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, Heart Transplant, Left Ventricular Assist Device Implantation
Measured: 5 years
Secondary outcomes (1)
Hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javed Butler, MD, Emory University
- Investigators
- Javed Butler, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599014
- Sponsor's protocol ID
- IRB00005380
- Acronym
- TACC
- Status last verified
- Aug 2015
- First submitted
- 11 Jan 2008
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Atlanta Cardiomyopathy Consortium
- ClinicalTrials.gov ID
- NCT00599014
- Acronym / sponsor ID
- TACC / IRB00005380
- Conditions
- Heart Failure
- Keywords
- Cardiomyopathy, heart failure, DNA,, echocardiography, messenger RNA, natural history
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Posted 1 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Medical history of the patient
- Medical history on the patient's family
- Survey data including health behaviors \& psychosocial variables
- Blood \& urine samples
- EKG
- Six minute Walk Test
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology and general medicine clinics; Inpatients from cardiology services
Key inclusion criteria (4 listed)
- Age: 18 years and over
- Sex: Both
- Ethnic Origin: All
- Diagnosis required to participate: Clinical diagnosis of systolic or diastolic heart failure
Key exclusion criteria (3 listed)
- Congenital heart disease
- Previous heart transplantation
- No primary infiltrative disease i.e. amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death, Heart Transplant, Left Ventricular Assist Device Implantation
Time frame: 5 years
1 secondary outcome
Hospitalization
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javed Butler, MD, MPH principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, Heart Transplant, Left Ventricular Assist Device Implantation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.