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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-26

Study Completion Date

2022-08-01

Brief Summary

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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

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Detailed Description

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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

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Atrial Fibrillation Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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WP1: AF + CKD

Anticoagulated participants with atrial fibrillation and chronic kidney disease

No interventions assigned to this group

WP1: AF + no CKD

Anticoagulated participants with atrial fibrillation and no chronic kidney disease

No interventions assigned to this group

WP1: no AF + CKD

Anticoagulated participants with chronic kidney disease and no atrial fibrillation

No interventions assigned to this group

WP1: no AF + no CKD

Anticoagulated participants without atrial fibrillation or chronic kidney disease

No interventions assigned to this group

WP2: AF + CKD

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

Statin

Intervention Type DRUG

Any statin therapy

Interventions

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Statin

Any statin therapy

Intervention Type DRUG

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No