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St. Vincent's Screening To Prevent Heart Failure Study (STOP-HF)

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ClinicalTrials.gov Identifier: NCT00921960
Recruitment Status : Unknown
Verified December 2012 by Mark Ledwidge, St Vincent's University Hospital, Ireland.
Recruitment status was:  Recruiting
First Posted : June 17, 2009
Last Update Posted : December 13, 2012
Sponsor:
Collaborators:
The Heartbeat Trust
Crofton Cardiac Centre, Dublin
University College Dublin
University College Cork
Information provided by (Responsible Party):
Mark Ledwidge, St Vincent's University Hospital, Ireland

Brief Summary:
The STOP-HF study is a prospective, randomized, controlled trial recruiting asymptomatic individuals with risk factors for left ventricular dysfunction from 50 primary care clinics in Dublin and south east Ireland. It is designed to determine whether using natriuretic peptide measurement as a screening tool following a general cardiovascular risk factor screen will reduce the prevalence and severity of ventricular dysfunction in conjunction with specialist follow-up at St. Vincent's University Hospital.

Condition or disease Intervention/treatment Phase
Left Ventricular Dysfunction Myocardial Infarction Hypertension Diabetes Obesity Other: Intervention Care Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: St. Vincent's Screening To Prevent Heart Failure (STOP-HF) Study Using Natriuretic Peptides to Identify and Prevent Progression of Left Ventricular Dysfunction in Community Based, Asymptomatic, At-risk Individuals.
Study Start Date : January 2005
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Usual Care will involve ongoing management from the general practitioner, nurse-led assessment of cardiovascular risk at the general practice and referral to specialist services as deemed necessary.
Intervention
Intervention Care is defined as a collaborative cardiovascular management between primary care and specialist hospital based services. This will involve natriuretic peptide guided evaluation of LVD and follow-up as appropriate
Other: Intervention Care
Intervention Care is defined as a collaborative cardiovascular management between primary care and specialist hospital based services. This will involve natriuretic peptide guided evaluation of LVD and follow-up as appropriate - for example including echocardiographic assessment of left ventricular systolic dysfunction and appropriate pharmacotherapy.
Other Names:
  • Screening
  • Health services delivery intervention




Primary Outcome Measures :
  1. Prevalence and severity of LVD [ Time Frame: 5 year ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥40 Years of age
  • with risk factors for LVD including:

    • hypertension (medicated for ≥ 1 month)
    • hypercholesterolemia
    • obesity
    • coronary artery disease (confirmed by angiography)
    • diabetes mellitus
    • arrhythmia
    • valvular abnormalities

Exclusion Criteria:

  • failure or unwilling to provide informed consent
  • known ventricular dysfunction (confirmed by angiography or echocardiography)
  • previous documented episode of heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921960


Contacts
Contact: Kenneth M McDonald, MD +35312304629 kenneth.mcdonald@ucd.ie
Contact: Mark T Ledwidge, PhD +35312304629 mark@heartbeat-trust.org

Locations
Ireland
St Vincent's University Hospital Recruiting
Dublin, Ireland
Sub-Investigator: Carmel M Conlon, BSc         
Sub-Investigator: Ian M Dawkins, PhD         
Sub-Investigator: Donal O'Shea, MD         
Sub-Investigator: Elaine Tallon, MSc         
Sponsors and Collaborators
St Vincent's University Hospital, Ireland
The Heartbeat Trust
Crofton Cardiac Centre, Dublin
University College Dublin
University College Cork
Investigators
Principal Investigator: Kenneth M McDonald, MD St Vincent's University Hospital
Principal Investigator: Mark T Ledwidge, PhD St Vincent's University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Ledwidge, Research Director, Heart Failure Unit St Vincent's University Hospital, St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier: NCT00921960     History of Changes
Other Study ID Numbers: SVUH - HFU - 020
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by Mark Ledwidge, St Vincent's University Hospital, Ireland:
Left ventricular dysfunction
Left ventricular systolic dysfunction
Left ventricular diastolic dysfunction
Myocardial Infarction
Hypertension
Diabetes
Obesity
Dyslipidaemia
Heart Failure
Prevention
Screening
Cardiovascular Risk Factors
Echocardiography
Natriuretic Peptides

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Hypertension
Heart Failure
Infarction
Myocardial Infarction
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia