Monitoring Community Trends in Heart Failure

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035724
• Other study ID #: 1039
• Secondary ID: R37HL069874
• Status: Completed
• Phase: N/A
• First received: May 4, 2002
• Last updated: July 28, 2016
• Start date: April 2002
• Est. completion date: March 2007

Study information

• Verified date: May 2009
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its therapeutic management, and changes over time in the hospital and long-term survival of patients with heart failure.

Description:

BACKGROUND:

Heart failure is estimated to contribute to nearly 1 million hospitalizations and approximately 250,000 deaths annually in the U.S. The number of new cases of heart failure in the U.S. is estimated to exceed 400,000 annually. Though reliable estimates of the magnitude, incidence, and mortality of heart failure remain sorely lacking, heart failure is associated with a grim prognosis. However, little recent data exist, particularly from a community-wide perspective, to determine whether the incidence or survival associated with heart failure, and the management of this clinical syndrome, has changed over time.

DESIGN NARRATIVE:

The study uses residents of the Worcester (MA) metropolitan area (1990 census 437,000) and examines changes over time in these and additional outcomes for patients with validated heart failure during 1995 and 2000. Complimenting the hospital surveillance of heart failure, newly diagnosed cases of heart failure occurring in members of the largest HMO in Central Massachusetts during 1995 and 2000 will be identified and monitored over time. To accomplish the study objectives, the medical records of residents of the Worcester metropolitan area hospitalized with a discharge diagnosis of heart failure and related diagnostic rubrics will be individually reviewed and validated according to pre-established diagnostic criteria. The use of traditional criteria for heart failure as well as development of new criteria for the epidemiological study of heart failure will be an important focus of this observational study. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term survival of discharged hospital patients through the year 2005.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Heart Failure, Congestive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Goldberg RJ, Glatfelter K, Burbank-Schmidt E, Farmer C, Spencer FA, Meyer T. Trends in mortality attributed to heart failure in Worcester, Massachusetts, 1992 to 2001. Am J Cardiol. 2005 Jun 1;95(11):1324-8. — View Citation

Goldberg RJ, Spencer FA, Farmer C, Meyer TE, Pezzella S. Incidence and hospital death rates associated with heart failure: a community-wide perspective. Am J Med. 2005 Jul;118(7):728-34. — View Citation