Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005534
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2000-05-25
Brief Title:
Prevalence of Asymptomatic Ventricular Dysfunction
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a population-based study of the prevalence of asymptomatic ventricular dysfunction
Detailed Description:
BACKGROUND
Chronic congestive heart failure CHF caused by left ventricular dysfunction LVD is a major cause of morbidity and mortality CHF is the major form of cardiovascular disease that is increasing in prevalence LVD progresses from an asymptomatic phase to a severe symptomatic phase Recent clinical trials have proven that angiotensin converting enzyme inhibitor reduced mortality morbidity and disease progression in asymptomatic patients with objectively measured LVD However available estimates of LVD prevalence are based on symptomatic patients not on objectively measured ventricular function parameters The distributions of ventricular function parameters in the United States population are unknown Since the prevalence of objectively measured asymptomatic LVD is unknown the total number of patients with LVD who could benefit from medical therapy is also not known Furthermore screening techniques to identify persons with treatable asymptomatic LVD have not been evaluated in a population-based setting The plasma concentration of n-atrial natriuretic peptide n-ANP is a marker for the presence of asymptomatic LVD that may be a valuable screening tool for asymptomatic LVD
DESIGN NARRATIVE
This is a population-based study of the distribution of ventricular function parameters in 2050 adult residents of Olmsted County MN and in collaboration with the Strong Heart study in 1522 adult Northern Plains American Indians This group of Northern Plains Indians is at increased risk for LVD having a higher prevalence of cardiovascular disease than the general United States population Subjects undergo echocardiography to measure ventricular function parameters as well as a clinical assessment of symptoms signs and risk factors for LVD Plasma concentration of n-ANP are measured in these populations to determine the accuracy of n-ANP as a noninvasive marker for asymptomatic LVD These studies provide comparative population-based estimates of ventricular function parameters and LVD in Olmsted County and Northern Plains Indians estimates of the magnitude of the population of patients that could benefit from current therapy current data on risk factors for prevalent CAD in these populations a foundation upon which future studies of incidence and clinical course of asymptomatic LVD could be based They also assess the accuracy of plasma n-ANP in identification of asymptomatic LVD
The study was renewed in May 2001 and will end in March 2005 Studies continue on testing the hypotheses that abnormalities of left ventricular systolicdiastolic function and left ventricular structure worsen over time that increasing plasma brain natriuretic peptide is associated with progressive change of left ventricular structure and function and that abnormal left ventricular structurefunction and brain natriuretic peptide are associated with incident clinical events
Chronic congestive heart failure CHF caused by left ventricular dysfunction LVD is a major cause of morbidity and mortality CHF is the major form of cardiovascular disease that is increasing in prevalence LVD progresses from an asymptomatic phase to a severe symptomatic phase Recent clinical trials have proven that angiotensin converting enzyme inhibitor reduced mortality morbidity and disease progression in asymptomatic patients with objectively measured LVD However available estimates of LVD prevalence are based on symptomatic patients not on objectively measured ventricular function parameters The distributions of ventricular function parameters in the United States population are unknown Since the prevalence of objectively measured asymptomatic LVD is unknown the total number of patients with LVD who could benefit from medical therapy is also not known Furthermore screening techniques to identify persons with treatable asymptomatic LVD have not been evaluated in a population-based setting The plasma concentration of n-atrial natriuretic peptide n-ANP is a marker for the presence of asymptomatic LVD that may be a valuable screening tool for asymptomatic LVD
DESIGN NARRATIVE
This is a population-based study of the distribution of ventricular function parameters in 2050 adult residents of Olmsted County MN and in collaboration with the Strong Heart study in 1522 adult Northern Plains American Indians This group of Northern Plains Indians is at increased risk for LVD having a higher prevalence of cardiovascular disease than the general United States population Subjects undergo echocardiography to measure ventricular function parameters as well as a clinical assessment of symptoms signs and risk factors for LVD Plasma concentration of n-ANP are measured in these populations to determine the accuracy of n-ANP as a noninvasive marker for asymptomatic LVD These studies provide comparative population-based estimates of ventricular function parameters and LVD in Olmsted County and Northern Plains Indians estimates of the magnitude of the population of patients that could benefit from current therapy current data on risk factors for prevalent CAD in these populations a foundation upon which future studies of incidence and clinical course of asymptomatic LVD could be based They also assess the accuracy of plasma n-ANP in identification of asymptomatic LVD
The study was renewed in May 2001 and will end in March 2005 Studies continue on testing the hypotheses that abnormalities of left ventricular systolicdiastolic function and left ventricular structure worsen over time that increasing plasma brain natriuretic peptide is associated with progressive change of left ventricular structure and function and that abnormal left ventricular structurefunction and brain natriuretic peptide are associated with incident clinical events
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL055502 | NIH | None | httpsreporternihgovquickSearchR01HL055502 |