Atrial FibrillationRALiCNCT04043026
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
An observational study of Atrial Fibrillation and Chronic Kidney Disease, run by University of Liverpool at 2 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Chronic Kidney Disease
- What is being tested?
- Statin
- How many people
- 56 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Sep 2019to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the hospital and specialist clinics in the community
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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liverpool Heart and Chest Hospital
Liverpool
Liverpool University Hospitals NHS Foundation Trust
Liverpool
About this study
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
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
Read the 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.
- Conditions
- Atrial Fibrillation, Chronic Kidney Disease
- Being tested
- Statin
- Keywords
- Anticoagulation, Fibrin clot structure and function, Lipids, Lipoproteins, Statin
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Any statin therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
WP1: Fibrin permeation analysis using validated test
Permeation constant (Ks)
Measured: At baseline
WP1: Low density lipoprotein fractions
Measure of low density lipoprotein subclass fractions
Measured: At baseline
WP1: Oxidised low density lipoprotein
Measure of oxidised low density lipoprotein
Measured: At baseline
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
Measured: At baseline and after 6 weeks of statin therapy
WP2: Fibrin permeation analysis using validated test
Permeation constant (Ks)
Measured: At baseline and after 6 weeks of statin
WP2: Low density lipoprotein fractions
Measure of low density lipoprotein subclass fractions
Measured: At baseline and after 6 weeks of statin
WP2: Oxidised low density lipoprotein
Measure of oxidised low density lipoprotein
Measured: At baseline and after 6 weeks of statin
Secondary outcomes (1)
WP1: Scanning electron microscopy
Qualitative assessment of fibril indices
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start26 Sep 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Slow recruitment due to COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool John Moores University, University of Leeds
- Responsible party
- Principal investigator, Wern Yew Ding, University of Liverpool
- Investigators
- Wern Yew Ding, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043026
- Sponsor's protocol ID
- UoL001456 - 4843
- Acronym
- RALiC
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2019
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04043026
- Acronym / sponsor ID
- RALiC / UoL001456 - 4843
- Conditions
- Atrial Fibrillation, Chronic Kidney Disease
- Keywords
- Anticoagulation, Fibrin clot structure and function, Lipids, Lipoproteins, Statin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment due to COVID19 pandemic
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool John Moores University, University of Leeds
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: StatinAnticoagulated participants with atrial fibrillation and chronic kidney disease, and are commencing statin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the hospital and specialist clinics in the community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinAny statin therapy | Drug | WP2: AF + CKD |
Primary outcome
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
WP1: Fibrin permeation analysis using validated test
Time frame: At baseline
Permeation constant (Ks)
WP1: Low density lipoprotein fractions
Time frame: At baseline
Measure of low density lipoprotein subclass fractions
WP1: Oxidised low density lipoprotein
Time frame: At baseline
Measure of oxidised low density lipoprotein
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
WP2: Fibrin permeation analysis using validated test
Time frame: At baseline and after 6 weeks of statin
Permeation constant (Ks)
WP2: Low density lipoprotein fractions
Time frame: At baseline and after 6 weeks of statin
Measure of low density lipoprotein subclass fractions
WP2: Oxidised low density lipoprotein
Time frame: At baseline and after 6 weeks of statin
Measure of oxidised low density lipoprotein
1 secondary outcome
WP1: Scanning electron microscopy
Time frame: At baseline
Results and safety
The study was stopped early (reason given: Slow recruitment due to COVID19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wern Yew Ding principal investigator
University of Liverpool
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Chronic Kidney Disease, run by University of Liverpool at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment due to COVID19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test (time frame: At baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.