NCT05814692

BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease

Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease

Detailed description

Background: Statin therapy is known to improve clinical outcomes in patients with coronary artery disease (CAD), while being highly cost-effective. However, adherence to statin therapy in real world settings is suboptimal and represents a possible target to ameliorate secondary CAD disease prevention. Previous interventional studies on statin adherence showed inconsistent results and it is widely acknowledged that a tailored adherence improvement approach adapted to patient determinants is required. However, methodology to accurately detect and characterize non-adherent patients is challenging and constitutes an important obstacle to developing such interventions. Urine analysis with liquid chromatography/mass spectrometry (LC-MS) for detection of statin intake is a promising method for objective measurement of adherence as an adjunct to subjective adherence assessment using questionnaires, which has not been applied in CAD patients in Germany. Objectives: In this pilot study (i) a feasibility testing of objective (LC-MS urine analysis) and subjective (questionnaire survey) measures of adherence to statin therapy will be performed, (ii) the prevalence of nonadherence in the target population will be determined , and (iii) instruments assessing possible factors associated with (non-)adherence (e.g. side effects, beliefs about medications, and disease-related knowledge) will be evaulated, in order to establish a methodological ground for further studies characterizing non-adherent patients. Methods: Outpatients with CAD treated in University Hospital Düsseldorf and receiving guideline-recommended atorvastatin or rosuvastatin on prescription will be included in the pilot study. Based on sample size calculation about 130 patients will be recruited. A biochemical method of objective urine measurement of statin intake by LC-MS will be combined with a preselected set of questionnaires on adherence behavior and associated factors. Clinical characteristics will be obtained from patient records. A sub-sample of the study population will be invited to participate in the interview for the evaluation of the questionnaire survey. Outlook: Based on the results of the pilot study, an adequately powered study to characterize non-adherent patients and identify patterns of non-adherence will be conducted. The results will be used for the development of a complex tailored intervention for non-adherent patients in Germany.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood and urine samples	blood and urine samples

Timeline

• Start date: 2022-09-14
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-04-18
• Last updated: 2023-05-06

Locations

1 site across 1 country: Germany