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

Sponsor

University of Liverpool (Other)

Overall Status

Terminated

CT.gov ID

NCT04043026

Collaborator

Liverpool Centre for Cardiovascular Science (Other), Liverpool Heart and Chest Hospital NHS Foundation Trust (Other), Liverpool John Moores University (Other), University of Leeds (Other)

Enrollment

Locations

34.2

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Chronic Kidney Disease	Drug: Statin

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 Design

Study Type:

Observational

Actual Enrollment :

56 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 26, 2019

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
WP1: AF + CKD Anticoagulated participants with atrial fibrillation and chronic kidney disease
WP1: AF + no CKD Anticoagulated participants with atrial fibrillation and no chronic kidney disease
WP1: no AF + CKD Anticoagulated participants with chronic kidney disease and no atrial fibrillation
WP1: no AF + no CKD Anticoagulated participants without atrial fibrillation or chronic kidney disease
WP2: AF + CKD Anticoagulated participants with atrial fibrillation and chronic kidney disease, and are commencing statin therapy	Drug: Statin Any statin therapy

Outcome Measures

Primary Outcome Measures

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
WP2: Oxidised low density lipoprotein [At baseline and after 6 weeks of statin]
Measure of oxidised low density lipoprotein

Secondary Outcome Measures

WP1: Scanning electron microscopy [At baseline]
Qualitative assessment of fibril indices

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liverpool Heart and Chest Hospital	Liverpool		United Kingdom
2	Liverpool University Hospitals NHS Foundation Trust	Liverpool		United Kingdom

Sponsors and Collaborators

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

Investigators

Principal Investigator: Wern Yew Ding, University of Liverpool

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wern Yew Ding, Clinical Research Fellow, University of Liverpool

ClinicalTrials.gov Identifier:

NCT04043026

Other Study ID Numbers:

UoL001456 - 4843

First Posted:

Aug 2, 2019

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wern Yew Ding, Clinical Research Fellow, University of Liverpool

Anticoagulation

Fibrin clot structure and function

Lipids

Lipoproteins

Statin

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Atrial Fibrillation

Study Results

No Results Posted as of Aug 8, 2022