The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
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|ClinicalTrials.gov Identifier: NCT02234492|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus (HIV) Cardiovascular Disease (CVD)||Drug: Rosuvastatin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Active Comparator: Rosuvastatin
Rosuvastatin 10mg once daily for 6 months.
Comparison of rosuvastatin to no rosuvastatin
Other Name: Crestor
No Intervention: No rosuvastatin
No rosuvastatin- this group will continue with their current medical therapy for 6 months.
- Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax). [ Time Frame: At baseline ]At baseline, correlation between CFR by MCE and vascular inflammation (TBRmax) by FDG-PET/CT will be assessed. We anticipate good overall concurrence.
- Change in CFR [ Time Frame: At 6 months ]Changes in CFR as measured by MCE will be evaluated over six months in HIV+ patients on ART and treated with rosuvastatin versus those not on a statin. Our study will be one of the first to examine the effects of rosuvastatin on measures of both inflammation and CFR in HIV+ patients.
- Change in TBRmax. [ Time Frame: At 6 months ]Changes in vascular inflammation (TBRmax) as measured by FDG-PET/CT will be evaluated over six months in HIV+ patients on ART and treated with rosuvastatin versus those not on a statin.
- Change in neurocognitive function [ Time Frame: At 6 months ]Changes in neurocognitve function as measured by a neuropsychological test battery (AMS-III Spatial Span, WAIS-R Digit Symbol, Hopkins Verbal Learning Test, Grooved Pegboard, Trail Making Tests A&B, Letter Numbering Sequencing , Patient's Assessment of Own Functioning, Center for Epidemiologic Studies-Depression Scale) will be evaluated over six months .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234492
|The Ottawa Hospital-General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Study Director:||Girish Dwivedi, MD MRCP PhD||University of Ottawa Heart Institute, Harry Perkins Institute of Medical Research|
|Principal Investigator:||Gary Small, MD MRCP||Ottawa Heart Institute Research Corporation|