Targeting Microvascular Dysfunction in Young Hypertensive Patients

NCT ID: NCT01047423

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Simvastatin

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

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

40mg encapsulated once daily for 12 weeks

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Encapsulated oral once daily for 12 weeks

Interventions

Simvastatin

40mg encapsulated once daily for 12 weeks

Intervention Type: DRUG

Placebo

Encapsulated oral once daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Gary E McVeigh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary E McVeigh, FRCP PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Belfast health and social care trust

Belfast, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 25888961 (View on PubMed)

Other Identifiers

2009-011638-90

Identifier Type: -

Identifier Source: org_study_id