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Prevalence of Asymptomatic Ventricular Dysfunction

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 5, 2014
    Sponsor
    Mayo Clinic
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005534
    Brief Title
    Prevalence of Asymptomatic Ventricular Dysfunction
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1997 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mayo Clinic
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Heart Failure

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Rodeheffer
    Organizational Affiliation
    Mayo Foundation

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9935024
    Citation
    Senni M, Rodeheffer RJ, Tribouilloy CM, Evans JM, Jacobsen SJ, Bailey KR, Redfield MM. Use of echocardiography in the management of congestive heart failure in the community. J Am Coll Cardiol. 1999 Jan;33(1):164-70. doi: 10.1016/s0735-1097(98)00523-3.
    Results Reference
    background
    PubMed Identifier
    9892327
    Citation
    Senni M, Tribouilloy CM, Rodeheffer RJ, Jacobsen SJ, Evans JM, Bailey KR, Redfield MM. Congestive heart failure in the community: trends in incidence and survival in a 10-year period. Arch Intern Med. 1999 Jan 11;159(1):29-34. doi: 10.1001/archinte.159.1.29.
    Results Reference
    background
    PubMed Identifier
    9826315
    Citation
    Senni M, Tribouilloy CM, Rodeheffer RJ, Jacobsen SJ, Evans JM, Bailey KR, Redfield MM. Congestive heart failure in the community: a study of all incident cases in Olmsted County, Minnesota, in 1991. Circulation. 1998 Nov 24;98(21):2282-9. doi: 10.1161/01.cir.98.21.2282.
    Results Reference
    background
    PubMed Identifier
    11231443
    Citation
    Devereux RB, Roman MJ, Paranicas M, Lee ET, Welty TK, Fabsitz RR, Robbins D, Rhoades ER, Rodeheffer RJ, Cowan LD, Howard BV. A population-based assessment of left ventricular systolic dysfunction in middle-aged and older adults: the Strong Heart Study. Am Heart J. 2001 Mar;141(3):439-46. doi: 10.1067/mhj.2001.113223.
    Results Reference
    background
    PubMed Identifier
    12225726
    Citation
    Redfield MM, Rodeheffer RJ, Jacobsen SJ, Mahoney DW, Bailey KR, Burnett JC Jr. Plasma brain natriuretic peptide concentration: impact of age and gender. J Am Coll Cardiol. 2002 Sep 4;40(5):976-82. doi: 10.1016/s0735-1097(02)02059-4.
    Results Reference
    background
    PubMed Identifier
    12517230
    Citation
    Redfield MM, Jacobsen SJ, Burnett JC Jr, Mahoney DW, Bailey KR, Rodeheffer RJ. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA. 2003 Jan 8;289(2):194-202. doi: 10.1001/jama.289.2.194.
    Results Reference
    background
    PubMed Identifier
    14566298
    Citation
    Munagala VK, Jacobsen SJ, Mahoney DW, Rodeheffer RJ, Bailey KR, Redfield MM. Association of newer diastolic function parameters with age in healthy subjects: a population-based study. J Am Soc Echocardiogr. 2003 Oct;16(10):1049-56. doi: 10.1016/S0894-7317(03)00516-9.
    Results Reference
    background
    PubMed Identifier
    12651054
    Citation
    Pritchett AM, Jacobsen SJ, Mahoney DW, Rodeheffer RJ, Bailey KR, Redfield MM. Left atrial volume as an index of left atrial size: a population-based study. J Am Coll Cardiol. 2003 Mar 19;41(6):1036-43. doi: 10.1016/s0735-1097(02)02981-9.
    Results Reference
    background
    PubMed Identifier
    14574056
    Citation
    Dyrbye LN, Redfield MM. The role of brain natriuretic peptide in population screening. Heart Fail Rev. 2003 Oct;8(4):349-54. doi: 10.1023/a:1026143231117.
    Results Reference
    background
    PubMed Identifier
    15184280
    Citation
    Redfield MM, Rodeheffer RJ, Jacobsen SJ, Mahoney DW, Bailey KR, Burnett JC Jr. Plasma brain natriuretic peptide to detect preclinical ventricular systolic or diastolic dysfunction: a community-based study. Circulation. 2004 Jun 29;109(25):3176-81. doi: 10.1161/01.CIR.0000130845.38133.8F. Epub 2004 Jun 7.
    Results Reference
    background
    PubMed Identifier
    15629380
    Citation
    Pritchett AM, Mahoney DW, Jacobsen SJ, Rodeheffer RJ, Karon BL, Redfield MM. Diastolic dysfunction and left atrial volume: a population-based study. J Am Coll Cardiol. 2005 Jan 4;45(1):87-92. doi: 10.1016/j.jacc.2004.09.054.
    Results Reference
    background
    PubMed Identifier
    15528061
    Citation
    Okura Y, Urban LH, Mahoney DW, Jacobsen SJ, Rodeheffer RJ. Agreement between self-report questionnaires and medical record data was substantial for diabetes, hypertension, myocardial infarction and stroke but not for heart failure. J Clin Epidemiol. 2004 Oct;57(10):1096-103. doi: 10.1016/j.jclinepi.2004.04.005.
    Results Reference
    background
    PubMed Identifier
    15350958
    Citation
    Jacobsen SJ, Mahoney DW, Redfield MM, Bailey KR, Burnett JC Jr, Rodeheffer RJ. Participation bias in a population-based echocardiography study. Ann Epidemiol. 2004 Sep;14(8):579-84. doi: 10.1016/j.annepidem.2003.11.001.
    Results Reference
    background
    PubMed Identifier
    15312852
    Citation
    Rodeheffer RJ. Measuring plasma B-type natriuretic peptide in heart failure: good to go in 2004? J Am Coll Cardiol. 2004 Aug 18;44(4):740-9. doi: 10.1016/j.jacc.2004.03.082.
    Results Reference
    background
    PubMed Identifier
    16203909
    Citation
    Redfield MM, Jacobsen SJ, Borlaug BA, Rodeheffer RJ, Kass DA. Age- and gender-related ventricular-vascular stiffening: a community-based study. Circulation. 2005 Oct 11;112(15):2254-62. doi: 10.1161/CIRCULATIONAHA.105.541078. Epub 2005 Oct 3.
    Results Reference
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    Prevalence of Asymptomatic Ventricular Dysfunction

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