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Prevalence of Asymptomatic Ventricular Dysfunction
This study has been completed.
Study NCT00005534   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: January 25, 2008   History of Changes

May 25, 2000
January 25, 2008
January 1997
March 2006   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00005534 on ClinicalTrials.gov Archive Site
 
 
 
Prevalence of Asymptomatic Ventricular Dysfunction
 

To conduct a population-based study of the prevalence of asymptomatic ventricular dysfunction.

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 2,050 adult residents of Olmsted County, MN and, in collaboration with the Strong Heart study, in 1,522 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 systolic/diastolic 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 structure/function and brain natriuretic peptide are associated with incident clinical events.

N/A
Observational
 
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure, Congestive
  • Heart Failure
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
March 2006
March 2006   (final data collection date for primary outcome measure)

No eligibility criteria

Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005534
 
5067
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Richard Rodeheffer Mayo Foundation
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

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