The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function

Stratifying Clinical Risk in Patients With Atrial Fibrillation and Chronic Kidney Disease by Studying How Abnormalities in Clot Structure/Function and Lipoproteins Contribute to Thrombosis and Bleeding

This study is designed to investigate the role of lipids/lipoproteins as a potential cause for the harmful changes seen in fibrin clot properties with renal dysfunction and atrial fibrillation

This is a prospective, observational, blinded study that will be conducted in two parts. The first study will assess the relationship between lipids/lipoproteins and fibrin clot properties among anticoagulated atrial fibrillation patients with and without renal dysfunction. The second study will assess the effects of statin therapy on lipids/lipoproteins and fibrin clot properties in anticoagulated atrial fibrillation patients with renal dysfunction. Renal dysfunction is defined as an estimated glomerular filtration rate below 50 ml/min/1.73m2 for the purposes for this trial.

6.1 Inclusion criteria

WP1:

• On anticoagulation therapy
• Informed consent obtained

WP2:

• Not receiving statins prior to recruitment
• Diagnosed atrial fibrillation
• On anticoagulation therapy
• Estimated glomerular filtration rate of <50 ml/min/1.73m2
• Informed consent obtained

6.2 Exclusion criteria

• Age <18 years
• Severe mitral stenosis or presence of metallic prosthetic valve
• Active or recent malignancy (<6 months)
• Active immunological disease
• Connective tissue disease
• Chronic liver disease
• Recent or chronic serious infection
• Chronic inflammatory disease
• Known haemophilia or thrombophilia
• Active bleeding
• Untreated hypothyroidism or hyperthyroidism
• Recent surgery (<3 months)
• Familial lipid disorders
• Concurrent use of steroids
• Dietary supplements known to influence lipids
• Contraindications/inability/unwillingness to commence statin (WP2)