- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043026
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
-
-
-
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
|
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
Collaborators
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
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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