Not provided
Not provided
Not provided
Not provided
Not provided
Slow recruitment due to COVID19 pandemic
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Liverpool Centre for Cardiovascular Science | UNKNOWN |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | OTHER |
| Liverpool John Moores University | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin | Drug | Any statin therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| WP1: Fibrin permeation analysis using validated test | Permeation constant (Ks) | At baseline |
| WP1: Low density lipoprotein fractions | Measure of low density lipoprotein subclass fractions | At baseline |
| WP1: Oxidised low density lipoprotein | Measure of oxidised low density lipoprotein | 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 | At baseline and after 6 weeks of statin therapy |
| WP2: Fibrin permeation analysis using validated test | Permeation constant (Ks) | At baseline and after 6 weeks of statin |
| WP2: Low density lipoprotein fractions | Measure of low density lipoprotein subclass fractions | At baseline and after 6 weeks of statin |
| WP2: Oxidised low density lipoprotein |
| Measure | Description | Time Frame |
|---|---|---|
| WP1: Scanning electron microscopy | Qualitative assessment of fibril indices | At baseline |
Not provided
6.1 Inclusion criteria
WP1:
WP2:
6.2 Exclusion criteria
Not provided
Not provided
Not provided
Participants will be recruited from the hospital and specialist clinics in the community
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wern Yew Ding | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom | ||||
| Liverpool University Hospitals NHS Foundation Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
Not provided
Not provided
| University of Leeds |
| OTHER |
Not provided
Not provided
Not provided
Measure of oxidised low density lipoprotein |
| At baseline and after 6 weeks of statin |
| Liverpool |
| United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |