Coronary Heart DiseaseNCT05814692
BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease
An observational study of Coronary Heart Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- blood and urine samples
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 14 Sep 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease and prescription of atorvastatin or rosuvastin
Who may be able to join
- patients with coronary artery disease
- prescription of atorvastatin or rosuvastatin
Who cannot join
- < 18 years
- impairment (e.g. dementia)
- language barrier (German)
- end-stage kidney disease with hemodialysis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Clinical Trial Unit, +492118105315, ctu@med.uni-duesseldorf.de
Maximillian Brockmeyer, MD
About this study
Official title: Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study
Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease
Read the 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
- Being tested
- blood and urine samples
- Keywords
- coronary artery disease, statin, atorvastatin, Rosuvastatin, adherence, biochemical urine testing of adherebnce
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urine samplesDiagnostic test
blood and urine samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Recrutiment Rate
Recruitment will be assessed by proportion of eligible patients (in %) that agree to participate in the study
Measured: through study completion, approximately 1 year
Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometr
Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometry
Measured: through study completion, approximately 1 year
Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.
Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.
Measured: through study completion, approximately 1 year
Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.
Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.
Measured: through study completion, approximately 1 year
Average time (in minutes) that is needed by the participants to complete the study questionnaire
Average time (in minutes) that is needed by the participants to complete the study questionnaire
Measured: through study completion, approximately 1 year
Rate of questions (in %) in the study questionnaire that are completely answered by participants
Rate of questions (in %) in the study questionnaire that are completely answered by participants
Measured: through study completion, approximately 1 year
Secondary outcomes (12)
Rate of patients (in %) in whom atorvastatin or rosuvastatin is detected by liquid chromatography/mass spectrometry analysis of a urine sample
Prevalence of statin adherence assessed by urine analysis
Measured: through study completion, approximately 1 year
Rate of patients (in %) who report good adherence atorvastatin or rosuvastatin assessed by Medical Adherence Report Scale (MARS-D)
Prevalence of statin adherence assessed by questionnaire
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on concomitant medication other than atorvastatin or rosuvastatin can be obtained from medical records
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on comorbidities (i.e., cerebrovascular disease, peripheral artery disease, arterial hypertension, and heart failure, or other comorbidities) can be obtained from medical records
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom socio-demographic information (i.e., level of education and income) can be obtained by the study questionnaire.
Rate of patients (in %) from whom socio-demographic information (i.e., level of education and income) can be obtained by the study questionnaire.
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on perceived side-effects of statin therapy can be obtained by the study questionnaire (open question).
Rate of patients (in %) from whom information on perceived side-effects of statin therapy can be obtained by the study questionnaire (open question).
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on patients' concerns about medications assessed by Beliefs about Medicines Questionnaire (BMQ-D) can be obtained by the study questionnaire
Rate of patients (in %) from whom information on patients' concerns about medications assessed by Beliefs about Medicines Questionnaire (BMQ-D) can be obtained by the study questionnaire
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on anxiety and depression on the Hospital Anxiety and Depression Scale can be obtained by the study questionnaire.
Rate of patients (in %) from whom information on anxiety and depression on the Hospital Anxiety and Depression Scale can be obtained by the study questionnaire.
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on health-related quality of life measured by the The Short Form (12) Health Survey (SF-12) can be obtained by the study questionnaire
Rate of patients (in %) from whom information on health-related quality of life measured by the The Short Form (12) Health Survey (SF-12) can be obtained by the study questionnaire
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on social integration measured by the Social Integration Index can be obtained by the study questionnaire
Rate of patients (in %) from whom information on social integration measured by the Social Integration Index can be obtained by the study questionnaire
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on social support measured by the Oslo-3-Social-Support-Scale can be obtained by the study questionnaire
Rate of patients (in %) from whom information on social support measured by the Oslo-3-Social-Support-Scale can be obtained by the study questionnaire
Measured: through study completion, approximately 1 year
Rate of patients (in %) from whom information on health locus of control (open question) can be obtained by the study questionnaire
Rate of patients (in %) from whom information on health locus of control (open question) can be obtained by the study questionnaire
Measured: through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start14 Sep 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814692
- Sponsor's protocol ID
- BIO-FACTS
- Status last verified
- May 2023
- First submitted
- 17 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brockmeyer M, Chernyak N, Droge D, Wessel H, Parco C, Hoss A, Vargas KG, Lin Y, Rickert A, Ritz S, Icks A, Kelm M, Wolff G, Temme O. Biochemical urine analysis of atorvastatin and rosuvastatin by LC-MS: a pilot study of an objective method to assess non-adherence. BMC Cardiovasc Disord. 2026 Jan 9;26(1):83. doi: 10.1186/s12872-025-05475-0.
PubMed 41507807
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study
- ClinicalTrials.gov ID
- NCT05814692
- Acronym / sponsor ID
- BIO-FACTS
- Conditions
- Coronary Heart Disease
- Keywords
- coronary artery disease, statin, atorvastatin, Rosuvastatin, adherence, biochemical urine testing of adherebnce
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease and prescription of atorvastatin or rosuvastin
Key inclusion criteria (2 listed)
- patients with coronary artery disease
- prescription of atorvastatin or rosuvastatin
Key exclusion criteria (4 listed)
- < 18 years
- impairment (e.g. dementia)
- language barrier (German)
- end-stage kidney disease with hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and urine samplesblood and urine samples | Diagnostic test | – |
Primary outcome
Recrutiment Rate
Time frame: through study completion, approximately 1 year
Recruitment will be assessed by proportion of eligible patients (in %) that agree to participate in the study
Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometr
Time frame: through study completion, approximately 1 year
Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometry
Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.
Time frame: through study completion, approximately 1 year
Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.
Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.
Time frame: through study completion, approximately 1 year
Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.
Average time (in minutes) that is needed by the participants to complete the study questionnaire
Time frame: through study completion, approximately 1 year
Average time (in minutes) that is needed by the participants to complete the study questionnaire
Rate of questions (in %) in the study questionnaire that are completely answered by participants
Time frame: through study completion, approximately 1 year
Rate of questions (in %) in the study questionnaire that are completely answered by participants
12 secondary outcomes
Rate of patients (in %) in whom atorvastatin or rosuvastatin is detected by liquid chromatography/mass spectrometry analysis of a urine sample
Time frame: through study completion, approximately 1 year
Rate of patients (in %) who report good adherence atorvastatin or rosuvastatin assessed by Medical Adherence Report Scale (MARS-D)
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on concomitant medication other than atorvastatin or rosuvastatin can be obtained from medical records
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on comorbidities (i.e., cerebrovascular disease, peripheral artery disease, arterial hypertension, and heart failure, or other comorbidities) can be obtained from medical records
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom socio-demographic information (i.e., level of education and income) can be obtained by the study questionnaire.
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on perceived side-effects of statin therapy can be obtained by the study questionnaire (open question).
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on patients' concerns about medications assessed by Beliefs about Medicines Questionnaire (BMQ-D) can be obtained by the study questionnaire
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on anxiety and depression on the Hospital Anxiety and Depression Scale can be obtained by the study questionnaire.
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on health-related quality of life measured by the The Short Form (12) Health Survey (SF-12) can be obtained by the study questionnaire
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on social integration measured by the Social Integration Index can be obtained by the study questionnaire
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on social support measured by the Oslo-3-Social-Support-Scale can be obtained by the study questionnaire
Time frame: through study completion, approximately 1 year
Rate of patients (in %) from whom information on health locus of control (open question) can be obtained by the study questionnaire
Time frame: through study completion, approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 41507807Brockmeyer M, Chernyak N, Droge D, Wessel H, Parco C, Hoss A, Vargas KG, Lin Y, Rickert A, Ritz S, Icks A, Kelm M, Wolff G, Temme O. Biochemical urine analysis of atorvastatin and rosuvastatin by LC-MS: a pilot study of an objective method to assess non-adherence. BMC Cardiovasc Disord. 2026 Jan 9;26(1):83. doi: 10.1186/s12872-025-05475-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malte Kelm, Prof. study chair
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maximillian Brockmeyer, MD (: +492118118800, maximilian.brockmeyer@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recrutiment Rate (time frame: through study completion, approximately 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.