Clinical trial NCT04043026: The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Chronic Kidney Disease
Keywords: Anticoagulation
Fibrin clot structure and function
Lipids
Lipoproteins
Statin
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Liverpool Centre for Cardiovascular Science
name: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Liverpool John Moores University
name: University of Leeds
First posted: 2019-08-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the hospital and specialist clinics in the community

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
timeFrame: At baseline
measure: WP1: Fibrin permeation analysis using validated test
timeFrame: At baseline
measure: WP1: Low density lipoprotein fractions
timeFrame: At baseline
measure: WP1: Oxidised low density lipoprotein
timeFrame: At baseline
measure: WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
timeFrame: At baseline and after 6 weeks of statin therapy
measure: WP2: Fibrin permeation analysis using validated test
timeFrame: At baseline and after 6 weeks of statin
measure: WP2: Low density lipoprotein fractions
timeFrame: At baseline and after 6 weeks of statin
measure: WP2: Oxidised low density lipoprotein
timeFrame: At baseline and after 6 weeks of statin
Secondary outcomes:
measure: WP1: Scanning electron microscopy
timeFrame: At baseline
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Liverpool
name: Wern Yew Ding
role: PRINCIPAL_INVESTIGATOR
References: