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

August 3, 2022 updated by: Wern Yew Ding, University of Liverpool

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital
      • Liverpool, United Kingdom
        • Liverpool University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the hospital and specialist clinics in the community

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
Time Frame: At baseline
Lag time, maximum absorbance, time to maximum absorbance and clot lysis time
At baseline
WP1: Fibrin permeation analysis using validated test
Time Frame: At baseline
Permeation constant (Ks)
At baseline
WP1: Low density lipoprotein fractions
Time Frame: At baseline
Measure of low density lipoprotein subclass fractions
At baseline
WP1: Oxidised low density lipoprotein
Time Frame: At baseline
Measure of oxidised low density lipoprotein
At baseline
WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
Time Frame: At baseline and after 6 weeks of statin therapy
Lag time, maximum absorbance, time to maximum absorbance and clot lysis time
At baseline and after 6 weeks of statin therapy
WP2: Fibrin permeation analysis using validated test
Time Frame: At baseline and after 6 weeks of statin
Permeation constant (Ks)
At baseline and after 6 weeks of statin
WP2: Low density lipoprotein fractions
Time Frame: At baseline and after 6 weeks of statin
Measure of low density lipoprotein subclass fractions
At baseline and after 6 weeks of statin
WP2: Oxidised low density lipoprotein
Time Frame: At baseline and after 6 weeks of statin
Measure of oxidised low density lipoprotein
At baseline and after 6 weeks of statin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WP1: Scanning electron microscopy
Time Frame: At baseline
Qualitative assessment of fibril indices
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liverpool

Collaborators

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

Investigators

  • Principal Investigator: Wern Yew Ding, University of Liverpool

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoL001456 - 4843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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