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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Connecticut Health Center
Sponsor:
Collaborator:
CT Department of Public Health
Information provided by (Responsible Party):
Bruce Liang, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00762008
First received: September 26, 2008
Last updated: April 24, 2014
Last verified: January 2014
  Purpose

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
Acute Decompensated Heart Failure
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Hospitalization for acute heart failure, myocardial infarction, stroke or death. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 250
Study Start Date: December 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762008

Contacts
Contact: Jayne M Schumacher, RN 860-679-2692 schumacher@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
CT Department of Public Health
Investigators
Principal Investigator: Bruce T. Liang, M.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Bruce Liang, Professor of Medicine; Director Pat and Jim Calhoun Cardiovascular Center, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00762008     History of Changes
Other Study ID Numbers: 06-151-2, 08145
Study First Received: September 26, 2008
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
biomarkers

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

ClinicalTrials.gov processed this record on August 21, 2014