NCT00599014

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 1, 2014

Completed
Last Updated

November 2, 2015

Status Verified

August 1, 2015

Enrollment Period

5.6 years

First QC Date

January 11, 2008

Results QC Date

November 13, 2013

Last Update Submit

October 4, 2015

Conditions

Keywords

Cardiomyopathy, heart failure, DNA,echocardiography, messenger RNA, natural history

Outcome Measures

Primary Outcomes (1)

  • Death, Heart Transplant, Left Ventricular Assist Device Implantation

    5 years

Secondary Outcomes (1)

  • Hospitalization

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiology and general medicine clinics; Inpatients from cardiology services

You may qualify if:

  • Age: 18 years and over
  • Sex: Both
  • Ethnic Origin: All
  • Diagnosis required to participate: Clinical diagnosis of systolic or diastolic heart failure

You may not qualify if:

  • Congenital heart disease
  • Previous heart transplantation
  • No primary infiltrative disease i.e. amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Atlanta, Georgia, 30308, United States

Location

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

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Heart FailureCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

Long baseline visit with several questionnaires to be completed made more difficult for the patients to be enrolled. Adverse Events data was not collected as part of this observational registry.

Results Point of Contact

Title
Dr. Javed Butler
Organization
Emory University

Study Officials

  • Javed Butler, MD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

November 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 2, 2015

Results First Posted

January 1, 2014

Record last verified: 2015-08

Locations