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

Atrial Fibrillation Clinical Trial

— RALiC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04043026
• Other study ID #: UoL001456 - 4843
• Status: Terminated
• Start date: September 26, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Statin
Any statin therapy

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool

Sponsors (5)

Lead Sponsor	Collaborator
University of Liverpool	Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool John Moores University, University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline
Primary	WP1: Fibrin permeation analysis using validated test	Permeation constant (Ks)	At baseline
Primary	WP1: Low density lipoprotein fractions	Measure of low density lipoprotein subclass fractions	At baseline
Primary	WP1: Oxidised low density lipoprotein	Measure of oxidised low density lipoprotein	At baseline
Primary	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	At baseline and after 6 weeks of statin therapy
Primary	WP2: Fibrin permeation analysis using validated test	Permeation constant (Ks)	At baseline and after 6 weeks of statin
Primary	WP2: Low density lipoprotein fractions	Measure of low density lipoprotein subclass fractions	At baseline and after 6 weeks of statin
Primary	WP2: Oxidised low density lipoprotein	Measure of oxidised low density lipoprotein	At baseline and after 6 weeks of statin
Secondary	WP1: Scanning electron microscopy	Qualitative assessment of fibril indices	At baseline