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

Terminated

• Conditions: Atrial Fibrillation; Chronic Kidney Disease
• Interventions: Drug: Statin

• Registration Number: NCT04043026
• Lead Sponsor: University of Liverpool

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.

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-02
• Study Start: 2019-09-26
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WP2: AF + CKD	Statin	Anticoagulated participants with atrial fibrillation and chronic kidney disease, and are commencing statin therapy

Primary Outcome Measures

Name	Time	Method
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
WP2: Oxidised low density lipoprotein	At baseline and after 6 weeks of statin	Measure of oxidised low density lipoprotein
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
WP1: Low density lipoprotein fractions	At baseline	Measure of low density lipoprotein subclass fractions
WP1: Fibrin permeation analysis using validated test	At baseline	Permeation constant (Ks)
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

Secondary Outcome Measures

Name	Time	Method
WP1: Scanning electron microscopy	At baseline	Qualitative assessment of fibril indices

Trial Locations

Locations (2)

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom