Cardiovascular DiseasesNCT00053534
Heart Failure in the Community
An observational study of Cardiovascular Diseases and Heart Diseases, run by Mayo Clinic.
Trial summary
To monitor trends in congestive heart failure in Olmsted County, Minnesota. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To monitor trends in congestive heart failure in Olmsted County, Minnesota.
Read the detailed description
BACKGROUND:
Heart failure (HF) is designated as an emerging epidemic. Yet, it is not fully characterized. Most data, derived from hospital discharges, cannot measure incidence, have uncertain validity and cannot capture the full burden of heart failure because of the shift towards outpatient care. Regarding its etiology, the respective role of hypertension and coronary heart disease (CHD) is controversial. Moreover, the prevalence of obesity and diabetes mellitus is increasing, both conditions linked to heart failure via several mechanisms such that their contribution to heart failure could conceivably be increasing but remains to be examined. Finally, while the existence of diastolic heart failure is recognized, its diagnosis is exclusionary based on symptoms of heart failure in the absence of left ventricular systolic dysfunction. This approach is unsatisfactory, thus the contribution of diastolic heart failure to heart failure remains contentious. These striking gaps in knowledge underscore the necessity of a rigorous investigation of the heart failure epidemic. Through surveillance of the Olmsted County community, previous studies have demonstrated the postponement of coronary heart disease towards older ages and the decline over time in the severity of hospitalized myocardial infarction and the incidence of heart failure after myocardial infarction. This implies that, if coronary heart disease is the main cause of heart failure, heart failure should be postponed towards older ages and its incidence rate relatively stable. During the same period, preliminary findings on heart failure surveillance suggest that the incidence of first clinical diagnosis of heart failure may not be increasing as much as implied by hospital discharges and that adverse trends may be occurring preferentially among younger ages. These data from the same community are challenging to reconcile with the concept of an ongoing major contribution of coronary heart disease to an epidemic of heart failure, thereby underscoring the need to rigorously study the epidemiology of heart failure.
DESIGN NARRATIVE:
The study has three specific aims and uses a community surveillance approach which is integrated with ongoing work on coronary heart disease surveillance to investigate the heart failure epidemic in Olmsted County by characterizing its magnitude and determinants and studying prospectively the contribution of diastolic heart failure. Aim 1 will estimate the secular trends in the incidence and in the outcome of validated heart failure to test the hypotheses that there has been an increase in the incidence of heart failure, which differs by age and sex and that the survival of heart failure improved while hospitalization for heart failure has increased. Aim 2 will use a case-control approach to characterize the etiology of heart failure and its changes over time and to test the hypotheses that coronary heart disease and hypertension confer an excess risk of heart failure, the magnitude of which is declining over time, that obesity and diabetes mellitus confer an excess risk of heart failure the magnitude of which is increasing and that the population attributable risk of coronary heart disease and hypertension for heart failure is declining, while that of obesity and diabetes mellitus is increasing over time. Aim 3 will prospectively characterize the contribution of diastolic heart failure to heart failure using brain natriuretic peptide (BNP) among persons with heart failure and define the prognostic value of BNP in all cases of heart failure.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Coronary Disease, Diabetes Mellitus, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Coronary Disease, Diabetes Mellitus, Hypertension, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2003 (estimated)
- Study startJan 2003
- Primary completionDec 2006
- Study completionDec 2006
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 Mayo ClinicThe 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
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Veronique Roger, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053534
- Sponsor's protocol ID
- 1207
- Other IDs
- R01HL072435
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2003
- Last updated
- 20 Feb 2014
- Results posted
- No
Publications
Bursi F, Enriquez-Sarano M, Nkomo VT, Jacobsen SJ, Weston SA, Meverden RA, Roger VL. Heart failure and death after myocardial infarction in the community: the emerging role of mitral regurgitation. Circulation. 2005 Jan 25;111(3):295-301. doi: 10.1161/01.CIR.0000151097.30779.04. Epub 2005 Jan 17.
PubMed 15655133Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50. doi: 10.1001/jama.292.3.344.
PubMed 15265849Pakhomov SV, Buntrock J, Chute CG. Prospective recruitment of patients with congestive heart failure using an ad-hoc binary classifier. J Biomed Inform. 2005 Apr;38(2):145-53. doi: 10.1016/j.jbi.2004.11.016.
PubMed 15797003
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure in the Community
- ClinicalTrials.gov ID
- NCT00053534
- Acronym / sponsor ID
- 1207
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Coronary Disease, Diabetes Mellitus, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 31 Jan 2003 (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 monitor trends in congestive heart failure in Olmsted County, Minnesota.
Detailed description
BACKGROUND:
Heart failure (HF) is designated as an emerging epidemic. Yet, it is not fully characterized. Most data, derived from hospital discharges, cannot measure incidence, have uncertain validity and cannot capture the full burden of heart failure because of the shift towards outpatient care. Regarding its etiology, the respective role of hypertension and coronary heart disease (CHD) is controversial. Moreover, the prevalence of obesity and diabetes mellitus is increasing, both conditions linked to heart failure via several mechanisms such that their contribution to heart failure could conceivably be increasing but remains to be examined. Finally, while the existence of diastolic heart failure is recognized, its diagnosis is exclusionary based on symptoms of heart failure in the absence of left ventricular systolic dysfunction. This approach is unsatisfactory, thus the contribution of diastolic heart failure to heart failure remains contentious. These striking gaps in knowledge underscore the necessity of a rigorous investigation of the heart failure epidemic. Through surveillance of the Olmsted County community, previous studies have demonstrated the postponement of coronary heart disease towards older ages and the decline over time in the severity of hospitalized myocardial infarction and the incidence of heart failure after myocardial infarction. This implies that, if coronary heart disease is the main cause of heart failure, heart failure should be postponed towards older ages and its incidence rate relatively stable. During the same period, preliminary findings on heart failure surveillance suggest that the incidence of first clinical diagnosis of heart failure may not be increasing as much as implied by hospital discharges and that adverse trends may be occurring preferentially among younger ages. These data from the same community are challenging to reconcile with the concept of an ongoing major contribution of coronary heart disease to an epidemic of heart failure, thereby underscoring the need to rigorously study the epidemiology of heart failure.
DESIGN NARRATIVE:
The study has three specific aims and uses a community surveillance approach which is integrated with ongoing work on coronary heart disease surveillance to investigate the heart failure epidemic in Olmsted County by characterizing its magnitude and determinants and studying prospectively the contribution of diastolic heart failure. Aim 1 will estimate the secular trends in the incidence and in the outcome of validated heart failure to test the hypotheses that there has been an increase in the incidence of heart failure, which differs by age and sex and that the survival of heart failure improved while hospitalization for heart failure has increased. Aim 2 will use a case-control approach to characterize the etiology of heart failure and its changes over time and to test the hypotheses that coronary heart disease and hypertension confer an excess risk of heart failure, the magnitude of which is declining over time, that obesity and diabetes mellitus confer an excess risk of heart failure the magnitude of which is increasing and that the population attributable risk of coronary heart disease and hypertension for heart failure is declining, while that of obesity and diabetes mellitus is increasing over time. Aim 3 will prospectively characterize the contribution of diastolic heart failure to heart failure using brain natriuretic peptide (BNP) among persons with heart failure and define the prognostic value of BNP in all cases of heart failure.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 20 Feb 2014.
- Background: PubMed 15655133Bursi F, Enriquez-Sarano M, Nkomo VT, Jacobsen SJ, Weston SA, Meverden RA, Roger VL. Heart failure and death after myocardial infarction in the community: the emerging role of mitral regurgitation. Circulation. 2005 Jan 25;111(3):295-301. doi: 10.1161/01.CIR.0000151097.30779.04. Epub 2005 Jan 17.
- Background: PubMed 15265849Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50. doi: 10.1001/jama.292.3.344.
- Background: PubMed 15797003Pakhomov SV, Buntrock J, Chute CG. Prospective recruitment of patients with congestive heart failure using an ad-hoc binary classifier. J Biomed Inform. 2005 Apr;38(2):145-53. doi: 10.1016/j.jbi.2004.11.016.
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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.
Veronique Roger
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2014. 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 NCT00053534, 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 20 Feb 2014; AzTrials last refreshed its copy on 5 Nov 2026.