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

University of Liverpool

Status: Terminated

Conditions: Chronic Kidney Disease; Atrial Fibrillation

Treatments: Drug: Statin

Study type: Observational

Funder types: Other

Identifiers

NCT04043026

UoL001456 - 4843

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

56 participants in 5 patient groups

WP1: AF + CKD

Description:

Anticoagulated participants with atrial fibrillation and chronic kidney disease

WP1: AF + no CKD

Description:

Anticoagulated participants with atrial fibrillation and no chronic kidney disease

WP1: no AF + CKD

Description:

Anticoagulated participants with chronic kidney disease and no atrial fibrillation

WP1: no AF + no CKD

Description:

Anticoagulated participants without atrial fibrillation or chronic kidney disease

WP2: AF + CKD

Description:

Anticoagulated participants with atrial fibrillation and chronic kidney disease, and are commencing statin therapy

Treatment:

Drug: Statin