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

NCT04043026 | Terminated

• 1 other identifier: UoL001456 - 4843
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

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

Conditions

Atrial Fibrillation; Chronic Kidney Disease

Keywords

Anticoagulation; Fibrin clot structure and function; Lipids; Lipoproteins; Statin

Outcome Measures

Primary Outcomes (8)

• 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 of oxidised low density lipoprotein

  At baseline and after 6 weeks of statin

Secondary Outcomes (1)

• WP1: Scanning electron microscopy

  At baseline

Study Arms (5)

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

Interventions

Statin DRUG

Any statin therapy

WP2: AF + CKD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency, Chronic

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Wern Yew Ding

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 2, 2019
• Study Start: September 26, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)