St. Vincent's Screening To Prevent Heart Failure Study
STOP-HF
1 other identifier
interventional
1,378
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 27, 2018
July 1, 2018
12.9 years
June 16, 2009
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence and severity of LVD
5 year
Study Arms (2)
Usual Care
NO INTERVENTIONUsual 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
OTHERIntervention 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- failure or unwilling to provide informed consent
- known ventricular dysfunction (confirmed by angiography or echocardiography)
- previous documented episode of heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St Vincent's University Hospital, Irelandlead
- University College Dublincollaborator
- Crofton Cardiac Centre, Dublincollaborator
- The Heartbeat Trustcollaborator
Study Sites (1)
St Vincent's University Hospital
Dublin, Ireland
Related Publications (5)
Sweeney C, Pharithi RB, Kerr B, Ryan C, Ryan F, Collins L, Halley C, Barrett M, Watson CJ, McDonald K, Ledwidge M. NT-proBNP/BNP ratio for prognostication in European Caucasian patients enrolled in a heart failure prevention programme. ESC Heart Fail. 2021 Dec;8(6):5081-5091. doi: 10.1002/ehf2.13576. Epub 2021 Sep 29.
PMID: 34586748DERIVEDWatson C, Spiers JP, Waterstone M, Russell-Hallinan A, Gallagher J, McDonald K, Ryan C, Gilmer J, Ledwidge M. Investigation of association of genetic variant rs3918242 of matrix metalloproteinase-9 with hypertension, myocardial infarction and progression of ventricular dysfunction in Irish Caucasian patients with diabetes: a report from the STOP-HF follow-up programme. BMC Cardiovasc Disord. 2021 Feb 12;21(1):87. doi: 10.1186/s12872-021-01860-7.
PMID: 33579197DERIVEDLedwidge MT, O'Connell E, Gallagher J, Tilson L, James S, Voon V, Bermingham M, Tallon E, Watson C, O'Hanlon R, Barry M, McDonald K. Cost-effectiveness of natriuretic peptide-based screening and collaborative care: a report from the STOP-HF (St Vincent's Screening TO Prevent Heart Failure) study. Eur J Heart Fail. 2015 Jul;17(7):672-9. doi: 10.1002/ejhf.286.
PMID: 26139583DERIVEDLedwidge M, Gallagher J, Conlon C, Tallon E, O'Connell E, Dawkins I, Watson C, O'Hanlon R, Bermingham M, Patle A, Badabhagni MR, Murtagh G, Voon V, Tilson L, Barry M, McDonald L, Maurer B, McDonald K. Natriuretic peptide-based screening and collaborative care for heart failure: the STOP-HF randomized trial. JAMA. 2013 Jul 3;310(1):66-74. doi: 10.1001/jama.2013.7588.
PMID: 23821090DERIVEDBermingham M, Hayden J, Dawkins I, Miwa S, Gibson D, McDonald K, Ledwidge M. Prospective analysis of LDL-C goal achievement and self-reported medication adherence among statin users in primary care. Clin Ther. 2011 Sep;33(9):1180-9. doi: 10.1016/j.clinthera.2011.07.007. Epub 2011 Aug 12.
PMID: 21840055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth M McDonald, MD
St Vincent's University Hospital, Ireland
- PRINCIPAL INVESTIGATOR
Mark T Ledwidge, PhD
St Vincent's University Hospital, Ireland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director, Heart Failure Unit St Vincent's University Hospital
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
January 1, 2005
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 27, 2018
Record last verified: 2018-07