Targeting Microvascular Dysfunction in Young Hypertensive Patients

NCT01047423 | Withdrawn Phase 4 DMC

• 1 other identifier: 2009-011638-90
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension endothelial dysfunction statin prevention

Outcome Measures

Primary Outcomes (1)

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

  0, 3, 4 and 7 months

Study Arms (2)

Simvastatin

EXPERIMENTAL

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

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Simvastatin DRUG

40mg encapsulated once daily for 12 weeks

Simvastatin

Placebo DRUG

Encapsulated oral once daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Belfast health and social care trust

Belfast, BT9 7BL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25888961 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Gary E McVeigh, FRCP PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

GB (1)