Community Surveillance of Congestive Heart Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

May 25, 2000

Last Updated Date

November 10, 2005

Start Date ^ICMJE

August 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005517 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Community Surveillance of Congestive Heart Failure

Official Title ^ICMJE

Brief Summary

To conduct a surveillance study of congestive heart failure (CHF).

Detailed Description

DESIGN NARRATIVE:

Systematic surveillance was conducted of CHF among residents, 35-84 years old, of the Minneapolis-St.Paul metropolitan area (population 2.45 million, 1995 estimate) in two complementary domains: 1) hospitalization for CHF in two calendar years, five years apart (1995 and the year 2000); and 2) newly diagnosed CHF over a 9-year period (1993-2001) among members of a large Health Maintenance Organization (HMO). The magnitude and characteristics of hospitalized CHF were assessed in all 21 acute care hospitals of the metropolitan area. One-third of all discharges with ICD-9 CHF codes were sampled randomly (n about 5,000 per surveillance year), abstracted by trained nurses, and classified according to clinical criteria and the results of diagnostic tests. Newly diagnosed CHF was distinguished from recurrent episodes of decompensated CHF by thorough review of the hospital record. A complementary perspective on CHF, including the outpatient setting, was provided by a systematic study of members of HealthPartners, one of the largest HMOs in Minneapolis-St. Paul. Using the HealthPartners database, all newly diagnosed CHF cases between January 1, 1993 and December 31, 2001 (n about 1,900) were identified and the diagnosis validated. Beginning in January 1, 1999, newly diagnosed CHF cases were identified on an ongoing basis (n about 600), surveyed by mail, and followed for one-year from the original diagnosis. Surveillance of the HealthPartners population supplemented hospital surveillance and contributed data on incidence, prevalence, treatment, use of resources, and patient outcomes.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History

Condition ^ICMJE

Cardiovascular Diseases
Heart Failure, Congestive
Heart Diseases
Heart Failure

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

No eligibility criteria

Gender

Both

Ages

35 Years to 84 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00005517

Responsible Party

Study ID Numbers ^ICMJE

5036

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

Eyal Shahar

University of Minnesota

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP