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

This study is currently recruiting participants.
Verified December 2012 by St Vincent's University Hospital, Ireland
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00921960
First received: June 16, 2009
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Left Ventricular Dysfunction
Myocardial Infarction
Hypertension
Diabetes
Obesity
 Other: Intervention Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St Vincent's University Hospital, Ireland:

Primary Outcome Measures:
  • Prevalence and severity of LVD [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: January 2005
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
  More Information

No publications provided by St Vincent's University Hospital, Ireland

Additional 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
Study First Received: June 16, 2009
Last Updated: December 11, 2012
Health Authority: Ireland: Ministry of Health
Ireland: Irish Medicines Board

Keywords provided by 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, Left
Ventricular Dysfunction
Diabetes Mellitus
Heart Failure
Hypertension
Infarction
Myocardial Infarction
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013