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WithdrawnNCT01047423Updated Jul 5, 2019

Targeting Microvascular Dysfunction in Young Hypertensive Patients

A Phase 4 interventional study of Simvastatin and Placebo in Hypertension, sponsored by Queen's University, Belfast. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Queen's University, Belfast · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. One way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a noninvasive technique known as ultrasound and with a simple blood test. The investigators are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised. The investigators hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.

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Conditions studied

  • Hypertension

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Keywords

  • Hypertension endothelial dysfunction statin prevention
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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • To be eligible for the study, all of the following criteria must be met:

    • All patients must have a diagnosis of essential hypertension with off treatment systolic pressure >140 mmHg and/or diastolic pressure >90 mmHg, measured at rest in the seated position on at least two separate occasions, at least 2 weeks apart.
    • Patients will be \< 50 years for men and \< 60 years for women.
    • Female patients of childbearing potential must be using a medically accepted means of contraception (that is, interuterine device, oral contraceptive, implant, DepoProvera or barrier devices). Female patients of childbearing age will be screened with a pregnancy test.
    • Patients will be typically already on antihypertensive therapy.
    • Patients must have a level of understanding sufficient to complete all tests and examinations required by the protocol and are able to understand and give informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded from the study if they meet any of the following criteria:

    • A history of diabetes mellitus, coronary artery or cerebrovascular disease, hypertensive retinopathy, hypertensive nephropathy, left ventricular hypertrophy or hyperlipidaemia warranting treatment as defined by the latest NICE guidelines which recommend an age based treatment strategy rather than one driven purely by lipid levels in isolation.
    • Abnormal baseline liver function (defined as AST or ALT > 3 times upper limit of normal), raised baseline creatinine kinase (CK) (defined as CK > 200 mmol/L), severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \< 30 mls/minute) or previous adverse event relating to either an ARB or statin in the past.
    • Female patients will be excluded if they are pregnant, intend to be pregnant or are lactating. Female patients of childbearing age will be screened with a pregnancy test.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Simvastatin

    40mg Simvastatin once daily for 12 weeks followed by 4 week washout period followed by placebo for 12 weeks

    Drug: Simvastatin

  • Placebo comparator
    Placebo

    Placebo for 12 weeks followed by 4 week washout period followed by 40mg Simvastatin once daily for 12 weeks

    Drug: Placebo

Interventions

  • DrugSimvastatin

    40mg encapsulated once daily for 12 weeks

  • DrugPlacebo

    Encapsulated oral once daily for 12 weeks

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What researchers measure

Primary outcomes

  1. To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.

    Time frame: 0, 3, 4 and 7 months

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Study locations

1 site
  • Belfast health and social care trust
    Belfast, BT9 7BL, United Kingdom
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References and documents

Publications

  • Bleakley C, McCann A, McClenaghan V, Hamilton PK, Millar A, Pumb R, Harbinson M, McVeigh GE. Ultrasound entropy may be a new non-invasive measure of pre-clinical vascular damage in young hypertensive patients. Cardiovasc Ultrasound. 2015 Mar 20;13:12. doi: 10.1186/s12947-015-0006-7. PubMed 25888961 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01047423
Lead sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust
Responsible party
Gary E McVeigh (Professor, Queen's University, Belfast) — Principal investigator
First posted
Jan 12, 2010
Start date
Aug 2009
Primary completion
Aug 2011 (estimated)
Completion
Aug 2011 (estimated)
Last update
Jul 5, 2019

Study contacts

Gary E McVeigh, FRCP PhD
principal investigator · Queen's University, Belfast

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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