NCT00762008

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Dec 2005Dec 2027

Study Start

First participant enrolled

December 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
19.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 12, 2025

Status Verified

July 1, 2025

Enrollment Period

22 years

First QC Date

September 26, 2008

Last Update Submit

August 10, 2025

Conditions

Keywords

biomarkers

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for acute heart failure, myocardial infarction, stroke or death.

    3 years

Study Arms (1)

Heart Failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Bruce T. Liang, M.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad E Shah

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine; Director Pat and Jim Calhoun Cardiovascular Center

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

December 1, 2005

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 12, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations