Status:
COMPLETED
The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Ontario HIV Treatment Network
Conditions:
Human Immunodeficiency Virus (HIV)
Cardiovascular Disease (CVD)
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the use of rosuvastatin in Human Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels, improves blood circulation in...
Detailed Description
HIV is a chronic inflammatory disease. Patients with HIV are at a high risk of cardiovascular disease (CVD) which may be related to this state of chronic inflammation. HIV infected individuals are at ...
Eligibility Criteria
Inclusion
- 40-90 years of age
- documented evidence of HIV infection
- on standard antiretroviral therapy(ART) for \>1 years
- viral load persistently below the limits of detection while on ART
- current Cluster of Differentiation Antigen 4 (CD4) count \>350 cells/microlitre
- baseline Framingham risk score of 10-20%
Exclusion
- uncontrolled diabetes mellitus (glycated hemoglobin (HbA1C) \>6.5% or fasting glucose \>7.0 mmol/L)
- uncontrolled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>90)
- known coronary artery disease (CAD) e.g. previous myocardial infarction, revascularization procedure, or history of angina
- chronic renal failure (glomerular filtration rate (GFR) \<60 ml/min)
- total cholesterol \>5.8 mmol/L
- Low-density lipoprotein (LDL) cholesterol \>4.0 mmol/L
- already receiving a statin for baseline dyslipidemia
- pregnant or lactating
- active untreated Hepatitis B or C
- diagnosis or clinical evidence of a concomitant inflammatory/autoimmune disease
- patients at baseline demonstrating regional perfusion abnormalities (confined to individual coronary territories) following stress MCE will be excluded and further management will be according to local best practice guidelines
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02234492
Start Date
September 1 2014
End Date
October 1 2018
Last Update
October 5 2018
Active Locations (2)
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1
The Ottawa Hospital-General Campus
Ottawa, Ontario, Canada, K1H 8L6
2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7