Clinical trial NCT02234492: The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
Official title: The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus (HIV)
Cardiovascular Disease (CVD)
Keywords: Human immunodeficiency virus (HIV)
Statin therapy
Cardiovascular disease (CVD)
Coronary Flow Reserve (CFR)
Positron Emission Tomography (PET)
Myocardial contrast echocardiography (MCE)
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Ontario HIV Treatment Network
First posted: 2014-09-09
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 the small arteries that provide nutrients to the heart muscle and improves neurocognitive function.

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 up to four times higher risk of suffering a heart attack (also know as acute coronary syndrome).

The medicine rosuvastatin, commonly used to treat high cholesterol, has been shown to reduce inflammation in arteries in the general population and also in patients with high risk for heart problems.

72 subjects with HIV infection will be enrolled and divided into 2 groups of 36.

Group 1: Treatment Group: Participants will receive a low dose of rosuvastatin, 10mg, for 6 months in addition to their current medical therapy.

Group 2: Control Group: Participants will not receive rosuvastatin for 6 months and will continue with their current medical therapy.

Participants in both groups will undergo blood tests, Myocardial Contrast Echocardiography (MCE) scan and a Positron Emission Tomography/Computed Tomography PET/CT scan using a radioactive tracer called fluorodeoxyglucose (FDG-PET), monocyte and serum cytokine studies at baseline and 6 months.

10 subjects without HIV will also be enrolled to undergo monocyte and serum cytokine blood tests only, for comparison.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax).
timeFrame: At baseline
Secondary outcomes:
measure: Change in CFR
timeFrame: At 6 months
measure: Change in TBRmax.
timeFrame: At 6 months
measure: Change in neurocognitive function
timeFrame: At 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital-General Campus
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research
name: Girish Dwivedi, MD MRCP PhD
role: STUDY_DIRECTOR
affiliation: Ottawa Heart Institute Research Corporation
name: Gary Small, MD MRCP
role: PRINCIPAL_INVESTIGATOR
References: