Targeting Microvascular Dysfunction in Young Hypertensive Patients

Hypertension Clinical Trial

Official title:

Targeting Microvascular Dysfunction in Young Hypertensive Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01047423
• Other study ID #: 2009-011638-90
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: July 2019
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Simvastatin
40mg encapsulated once daily for 12 weeks
• Placebo
Encapsulated oral once daily for 12 weeks

Locations

Country	Name	City	State
United Kingdom	Belfast health and social care trust	Belfast

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.		0, 3, 4 and 7 months