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Targeting Microvascular Dysfunction in Young Hypertensive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Queen's University, Belfast.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Research and development office
Belfast Health and Social Care Trust
Information provided by:
Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01047423
First received: January 11, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Simvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Targeting Microvascular Dysfunction in Young Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin
40mg Simvastatin once daily for 12 weeks followed by 4 week washout period followed by placebo for 12 weeks
Drug: Simvastatin
40mg encapsulated once daily for 12 weeks
Placebo Comparator: Placebo
Placebo for 12 weeks followed by 4 week washout period followed by 40mg Simvastatin once daily for 12 weeks
Drug: Placebo
Encapsulated oral once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047423

Contacts
Contact: Caroline Bleakley, MRCP 02890975774 c.bleakley@yahoo.co.uk
Contact: Gary E McVeigh, FRCP PhD 02890975772 g.mcveigh@qub.ac.uk

Locations
United Kingdom
Belfast health and social care trust Recruiting
Belfast, United Kingdom, BT9 7BL
Contact: Caroline Bleakley, MRCP    028090975774    c.bleakley@yahoo.co.uk   
Sponsors and Collaborators
Queen's University, Belfast
Research and development office
Belfast Health and Social Care Trust
Investigators
Principal Investigator: Gary E McVeigh, FRCP PhD Queen's University, Belfast
  More Information

No publications provided

Responsible Party: Belfast health and social care trust
ClinicalTrials.gov Identifier: NCT01047423     History of Changes
Other Study ID Numbers: 2009‐011638‐90
Study First Received: January 11, 2010
Last Updated: January 11, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Queen's University, Belfast:
Hypertension endothelial dysfunction statin prevention

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014