Cardiovascular DiseasesNCT00005517
Community Surveillance of Congestive Heart Failure
An observational study of Cardiovascular Diseases and Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a surveillance study of congestive heart failure (CHF). Read more about this study
- Who is it for?
- Ages 35 to 84 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Failure, Congestive, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1998to Jun 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To conduct a surveillance study of congestive heart failure (CHF).
Read the 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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1998
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Eyal Shahar, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005517
- Sponsor's protocol ID
- 5036
- Other IDs
- R01HL060959
- Status last verified
- Nov 2005
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
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. doi: 10.1016/j.cardfail.2004.02.003.
PubMed 15470646Goldberg 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. doi: 10.1016/j.amjmed.2005.04.013.
PubMed 15989906Goldberg 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. doi: 10.1016/j.amjcard.2005.01.076.
PubMed 15904637
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Surveillance of Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00005517
- Acronym / sponsor ID
- 5036
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1998
- Study completion
- Jun 2004 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Background: PubMed 15470646Shahar 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. doi: 10.1016/j.cardfail.2004.02.003.
- Background: PubMed 15989906Goldberg 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. doi: 10.1016/j.amjmed.2005.04.013.
- Background: PubMed 15904637Goldberg 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. doi: 10.1016/j.amjcard.2005.01.076.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Shahar
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.