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Assessment of Vascular Function in Patients With Chronic Kidney Disease
Published on: June 16, 2014
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Management of Cardiovascular Disease in Kidney Disease Study: Rationale and Design
Ashutosh M Shukla1,2, Mark S Segal3,4, Carl J Pepine5
1Department of Medicine, North Florida/South Georgia Veterans Health System, Gainesville, Florida, USA, ashutosh.shukla@medicine.ufl.edu.
American Journal of Nephrology
|February 28, 2021
Summary
Low-dose hydroxychloroquine may reduce cardiovascular disease risk in chronic kidney disease (CKD) patients by targeting inflammation and vascular stiffness. This study investigates its potential benefits for atherosclerosis and cardiovascular mortality in CKD.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Cardiovascular disease (CVD) is a leading cause of mortality in chronic kidney disease (CKD) patients, with conventional treatments showing limited efficacy.
- Atherosclerosis, inflammation, and vascular stiffness are key interrelated risk factors for CVD in CKD.
- Low-dose hydroxychloroquine has demonstrated anti-inflammatory and vascular protective effects in preclinical and rheumatologic studies.
Purpose of the Study:
- To evaluate the efficacy of low-dose hydroxychloroquine in mitigating atherosclerosis, inflammation, and vascular stiffness in patients with CKD.
- To test the hypothesis that hydroxychloroquine offers significant cardiovascular benefits in the CKD population.
- To provide proof-of-applicability for hydroxychloroquine as a novel therapy for CVD in CKD.
Main Methods:
- A phase 2B, randomized, double-blind, placebo-controlled trial (NCT03636152) involving 100 high-risk CKD patients.
- Treatment with low-dose hydroxychloroquine or placebo for 18 months.
- Assessment of changes in carotid plaque volume, inflammation markers, vascular stiffness, and renal function.
Main Results:
- Primary outcome: Change in total carotid plaque volume via serial noncontrast carotid MRI.
- Secondary outcomes: Serial changes in plasma inflammation markers, vascular stiffness, renal function, and carotid plaque composition.
- The study aims to establish the impact of hydroxychloroquine on key CVD parameters in CKD.
Conclusions:
- This trial will determine the potential of hydroxychloroquine for treating cardiovascular disease in CKD patients.
- Positive results could support larger phase-3 trials investigating clinical endpoints.
- Hydroxychloroquine represents a potentially transformative, inexpensive therapeutic option for CVD in CKD.
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