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Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure

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ClinicalTrials.gov Identifier: NCT00762008
Recruitment Status : Recruiting
First Posted : September 30, 2008
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
CT Department of Public Health
Information provided by (Responsible Party):
Bruce Liang, UConn Health

Study Description
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Brief Summary:
The purpose of this research is to determine if two proteins in the blood are increased during acute heart failure. These two proteins are produced when the heart becomes dysfunctional and unable to contract normally. They may then be released into the blood and be detected by standard method in the research laboratory. Thus, the purpose of this study is to determine the relation between the change of these two proteins in the blood and the occurrence of acute heart failure. At this time, detection of an increase in these proteins in the blood is not known to be associated with any disease or heart failure.

Condition or disease
Acute Decompensated Heart Failure Heart Failure

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Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure
Study Start Date : December 2005
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Heart Failure


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization for acute heart failure, myocardial infarction, stroke or death. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Recruitment will take place in the University of Connecticut Health Center, both hospital inpatients and Cardiopulmonary clinic out-patients.

  1. The target population will be heart failure patients of any etiology. We anticipate that 20% of all recruited subjects will be African American and 5% to be Hispanic. This represents the distribution of populations recruited in the past for heart failure studies.
  2. Healthy individuals with no prior history of heart attack or heart failure will be recruited to use as controls.
Criteria

Inclusion Criteria:

  • Individuals aged >18yrs
  • stable or decompensated heart failure, irrespective of LVEF
  • decompensated heart failure clinical symptoms such as dyspnea, rales, edema, elevated jugular venous pressure, or ascites
  • Imaging evidence of heart failure (cardiomegaly, poor contractile function or echocardiographic Doppler evidence of diastolic dysfunction or elevated right- or left-sided filling pressures)
  • Healthy individuals with no prior history of heart attack or heart failure will be recruited to use as controls.

Exclusion Criteria:

  • Subjects who are unable to give informed consent
  • Subjects who had undergone cardiac or non-cardiac surgery in the 3 months before enrollment
  • Pregnant subjects are not excluded
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762008


Contacts
Contact: Sharon E DiMauro, MA 860-679-2692 dimauro@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
CT Department of Public Health
Investigators
Principal Investigator: Bruce T. Liang, M.D. UConn Health
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bruce Liang, Professor of Medicine; Director Pat and Jim Calhoun Cardiovascular Center, UConn Health
ClinicalTrials.gov Identifier: NCT00762008     History of Changes
Other Study ID Numbers: 06-151-2
08145
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Keywords provided by Bruce Liang, UConn Health:
biomarkers

Additional relevant MeSH terms:
Heart Failure
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical