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Targeting Microvascular Dysfunction in Young Hypertensive Patients

Primary Purpose

Hypertension

Status

Withdrawn

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Simvastatin

Placebo

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Hypertension endothelial dysfunction statin prevention

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Belfast health and social care trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01047423

First Posted

January 11, 2010

Last Updated

July 1, 2019

Sponsor

Queen's University, Belfast

Collaborators

Belfast Health and Social Care Trust

1. Study Identification

Unique Protocol Identification Number

NCT01047423

Brief Title

Targeting Microvascular Dysfunction in Young Hypertensive Patients

Official Title

Targeting Microvascular Dysfunction in Young Hypertensive Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Study Start Date

August 2009 (undefined)

Primary Completion Date

August 2011 (Anticipated)

Study Completion Date

August 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University, Belfast

Collaborators

Belfast Health and Social Care Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension endothelial dysfunction statin prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

40mg encapsulated once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Encapsulated oral once daily for 12 weeks

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary E McVeigh, FRCP PhD

Organizational Affiliation

Queen's University, Belfast

Official's Role

Principal Investigator

Facility Information:

Facility Name

Belfast health and social care trust

City

Belfast

ZIP/Postal Code

BT9 7BL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25888961

Citation

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.

Results Reference

derived

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Targeting Microvascular Dysfunction in Young Hypertensive Patients

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