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

University of Liverpool56 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation Chronic Kidney Disease

Interventions

StatinDRUG

Any statin therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Outcomes

Primary Outcomes

WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test

Lag time, maximum absorbance, time to maximum absorbance and clot lysis time

Time frame: At baseline

WP1: Fibrin permeation analysis using validated test

Permeation constant (Ks)

Time frame: At baseline

WP1: Low density lipoprotein fractions

Measure of low density lipoprotein subclass fractions

Time frame: At baseline

WP1: Oxidised low density lipoprotein

Measure of oxidised low density lipoprotein

Time frame: At baseline

WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test

Lag time, maximum absorbance, time to maximum absorbance and clot lysis time

Time frame: At baseline and after 6 weeks of statin therapy

WP2: Fibrin permeation analysis using validated test

Permeation constant (Ks)

Time frame: At baseline and after 6 weeks of statin

WP2: Low density lipoprotein fractions

Measure of low density lipoprotein subclass fractions

Time frame: At baseline and after 6 weeks of statin

WP2: Oxidised low density lipoprotein

Measure of oxidised low density lipoprotein

Time frame: At baseline and after 6 weeks of statin

Secondary Outcomes

Data from ClinicalTrials.gov

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