Atrial Fibrillation, Chronic Kidney Disease
Conditions
Keywords
Anticoagulation, Fibrin clot structure and function, Lipids, Lipoproteins, Statin
Brief summary
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
Detailed description
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.
Interventions
DRUGStatin
Any statin therapy
Sponsors
Liverpool Centre for Cardiovascular Science
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool John Moores University
University of Leeds
University of Liverpool
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WP2: Oxidised low density lipoprotein | At baseline and after 6 weeks of statin | Measure of oxidised low density lipoprotein |
| WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test | At baseline | Lag time, maximum absorbance, time to maximum absorbance and clot lysis time |
| WP1: Fibrin permeation analysis using validated test | At baseline | Permeation constant (Ks) |
| WP1: Low density lipoprotein fractions | At baseline | Measure of low density lipoprotein subclass fractions |
| WP1: Oxidised low density lipoprotein | At baseline | Measure of oxidised low density lipoprotein |
| WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test | At baseline and after 6 weeks of statin therapy | Lag time, maximum absorbance, time to maximum absorbance and clot lysis time |
| WP2: Fibrin permeation analysis using validated test | At baseline and after 6 weeks of statin | Permeation constant (Ks) |
| WP2: Low density lipoprotein fractions | At baseline and after 6 weeks of statin | Measure of low density lipoprotein subclass fractions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WP1: Scanning electron microscopy | At baseline | Qualitative assessment of fibril indices |
Countries
United Kingdom
Outcome results
None listed