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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005517
Other study ID # 5036
Secondary ID R01HL060959
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 26, 2016
Start date August 1998
Est. completion date June 2004

Study information

Verified date November 2005
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 conduct a surveillance study of congestive heart failure (CHF).


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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 84 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

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

References & Publications (3)

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

Shahar E, Lee S, Kim J, Duval S, Barber C, Luepker RV. Hospitalized heart failure: rates and long-term mortality. J Card Fail. 2004 Oct;10(5):374-9. — View Citation

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