PolypharmacyNCT05247814
Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients
An observational study of Polypharmacy and Pharmacogenetics, run by RWTH Aachen University.
Trial summary
This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Polypharmacy, Pharmacogenetics, Pharmacogenomic Testing
- What is being tested?
- Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism, Adverse Drug Reaction detection and Falls Efficacy Scale International (FES-I)
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Feb 2032
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology
Who may be able to join
- 70 years or older
- Current drug therapy with three or more drugs
- Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic
- Sufficient mobility (minimum: Wheelchair mobility)
- Written informed consent of the patient or the legal representative
Who cannot join
- No sufficient communication possible
- Patients classified as terminally ill by the medical staff
- Patients, that are incapable to give their informed consent and who do not have a legal representative
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Individual Patient Risk Profiles for Adverse Drug Reactions: Establishing a Consecutive Research Cohort in an Interdisciplinary Polypharmacy Consultation Service of a Geriatric University Outpatient Department
This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.
Read the detailed description
Adverse drug reactions are common in older patients and can lead to severe outcomes such as falls, hospitalizations and death. They are dose-dependent and may for example be caused by inappropriate dosing due to a reduced kidney function. Also, the use of potentially inappropriate medications in older patients can result in a negative benefit-/ risk-ratio. Additionally, drug metabolism in older patients is altered due to a variety of reasons and pharmacogenetic variants of drug metabolizing enzymes can lead to a more than 10-fold interinidividual variation of drug clearance. The risk of the individual patient to experience an adverse drug reactions is determined by many reasons. Therefore, this study aims to identify patient risk profiles with regard to pharmacogenetics, drug interactions, impaired functional and cognitive status and individual drug metabolism.
Participants for this study will be consecutively recruited from patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology. Regardless of their participation in this study, patients in the outpatient clinic will perform several tests and questionnaires following the comprehensive geriatric assessment. The purpose of the cohort study is to document and evaluate routine health data collected in the outpatient clinic for polypharmacy in geriatric patients (laboratory tests as well as a comprehensive medication history with therapy recommendations issued by a subsequent pharmaceutical council for both the patients and the primary care physicians).
Procedures conducted specifically for this study are a long-term capture and detailed history of all suspected adverse drug reactions, examining the fear of falling (FES-I questionnaire) and blood sampling for exploratory pharmacogenomic analyses (on cohort level, not patient diagnostics).
Aim of the long-term cohort of geriatric patients with polypharmacy is to identify risk profiles for adverse drug reactions that are specific for the population of older individuals.
- Conditions
- Polypharmacy, Pharmacogenetics, Pharmacogenomic Testing, Drug-Related Side Effects and Adverse Reactions
- Being tested
- Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism, Adverse Drug Reaction detection, Falls Efficacy Scale International (FES-I)
- Keywords
- Geriatric Assessment, Medication Adherence, Aged, Aged, 80 and over, Medication therapy management, Pharmacists, Geriatricians, Clinical Pharmacology, Medication reconciliation, Hospital pharmacy services, Hospital outpatient clinics, nterdisciplinary Health Team
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolismGenetic
All planned interventions are explorative analyses of biological and genetic risk profiles that can contribute to patients' individual risk for adverse drug reactions, i.e. due to variability in drug metabolism
Adverse Drug Reaction detectionOther
During appointments in the university outpatient clinic, patients will undergo a comprehensive adverse drug reaction (ADR) assessment based on an ADR diary they were handed at enrolment
Falls Efficacy Scale International (FES-I)Other
The FES-I wil be obtained to estimate fear of falling
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to interdisciplinary polypharmacy consultation service | Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology Receives: Genetic: Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism; Other: Adverse Drug Reaction detection; Other: Falls Efficacy Scale International (FES-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of vulnerability profiles of adverse drug reactions
To investigate patient-specific risk profiles for adverse drug reactions, the focus of this study is on analizing patients' functional and cognitive status, pharmacogenetics, and individual metabolic capacity (phenotype/genotype relationship).
Measured: February 2022 - February 2032
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study startJul 2022 (estimated)
- Primary completionFeb 2032 (estimated)
- Study completionFeb 2032 (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 PolypharmacyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Foundation
- Responsible party
- Principal investigator, Julia Stingl, RWTH Aachen University
- Investigators
- Julia C. Stingl, MD, ScD, Principal investigator, Institute of Clinical Pharmacology, University Hospital RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247814
- Sponsor's protocol ID
- 21-216
- Status last verified
- Jun 2022
- First submitted
- 9 Feb 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laurentius T, Al-Musawer E, Schmitz K, Bollheimer C, Wozniak J, Graeff V, Kriegisch-Stumpf A, Knuppel-Ruppert A, Dormann H, Stingl JC, Just KS. Influence of drugs on blood potassium levels in older, multi-medicated patients - results of two cohort studies focusing on adverse drug reactions. BMC Geriatr. 2026 Jun 27;26(1):881. doi: 10.1186/s12877-026-07899-5.
PubMed 42374247
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Risk Profiles for Adverse Drug Reactions: Establishing a Consecutive Research Cohort in an Interdisciplinary Polypharmacy Consultation Service of a Geriatric University Outpatient Department
- ClinicalTrials.gov ID
- NCT05247814
- Acronym / sponsor ID
- 21-216
- Conditions
- Polypharmacy, Pharmacogenetics, Pharmacogenomic Testing, Drug-Related Side Effects and Adverse Reactions
- Keywords
- Geriatric Assessment, Medication Adherence, Aged, Aged, 80 and over, Medication therapy management, Pharmacists, Geriatricians, Clinical Pharmacology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- B. Braun Foundation
- Study start
- Jul 2022 (estimated)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 21 Feb 2022 (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.
This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.
Detailed description
Adverse drug reactions are common in older patients and can lead to severe outcomes such as falls, hospitalizations and death. They are dose-dependent and may for example be caused by inappropriate dosing due to a reduced kidney function. Also, the use of potentially inappropriate medications in older patients can result in a negative benefit-/ risk-ratio. Additionally, drug metabolism in older patients is altered due to a variety of reasons and pharmacogenetic variants of drug metabolizing enzymes can lead to a more than 10-fold interinidividual variation of drug clearance. The risk of the individual patient to experience an adverse drug reactions is determined by many reasons. Therefore, this study aims to identify patient risk profiles with regard to pharmacogenetics, drug interactions, impaired functional and cognitive status and individual drug metabolism.
Participants for this study will be consecutively recruited from patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology. Regardless of their participation in this study, patients in the outpatient clinic will perform several tests and questionnaires following the comprehensive geriatric assessment. The purpose of the cohort study is to document and evaluate routine health data collected in the outpatient clinic for polypharmacy in geriatric patients (laboratory tests as well as a comprehensive medication history with therapy recommendations issued by a subsequent pharmaceutical council for both the patients and the primary care physicians).
Procedures conducted specifically for this study are a long-term capture and detailed history of all suspected adverse drug reactions, examining the fear of falling (FES-I questionnaire) and blood sampling for exploratory pharmacogenomic analyses (on cohort level, not patient diagnostics).
Aim of the long-term cohort of geriatric patients with polypharmacy is to identify risk profiles for adverse drug reactions that are specific for the population of older individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to interdisciplinary polypharmacy consultation service | – | Genetic: Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism, Other: Adverse Drug Reaction detection, Other: Falls Efficacy Scale International (FES-I)Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology
Key inclusion criteria (5 listed)
- 70 years or older
- Current drug therapy with three or more drugs
- Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic
- Sufficient mobility (minimum: Wheelchair mobility)
- Written informed consent of the patient or the legal representative
Key exclusion criteria (3 listed)
- No sufficient communication possible
- Patients classified as terminally ill by the medical staff
- Patients, that are incapable to give their informed consent and who do not have a legal representative
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 |
|---|---|---|
| Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolismAll planned interventions are explorative analyses of biological and genetic risk profiles that can contribute to patients' individual risk for adverse drug reactions, i.e. due to variability in drug metabolism | Genetic | Patients admitted to interdisciplinary polypharmacy consultation service |
| Adverse Drug Reaction detectionDuring appointments in the university outpatient clinic, patients will undergo a comprehensive adverse drug reaction (ADR) assessment based on an ADR diary they were handed at enrolment | Other | Patients admitted to interdisciplinary polypharmacy consultation service |
| Falls Efficacy Scale International (FES-I)The FES-I wil be obtained to estimate fear of falling | Other | Patients admitted to interdisciplinary polypharmacy consultation service |
Primary outcome
Identification of vulnerability profiles of adverse drug reactions
Time frame: February 2022 - February 2032
To investigate patient-specific risk profiles for adverse drug reactions, the focus of this study is on analizing patients' functional and cognitive status, pharmacogenetics, and individual metabolic capacity (phenotype/genotype relationship).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 42374247Laurentius T, Al-Musawer E, Schmitz K, Bollheimer C, Wozniak J, Graeff V, Kriegisch-Stumpf A, Knuppel-Ruppert A, Dormann H, Stingl JC, Just KS. Influence of drugs on blood potassium levels in older, multi-medicated patients - results of two cohort studies focusing on adverse drug reactions. BMC Geriatr. 2026 Jun 27;26(1):881. doi: 10.1186/s12877-026-07899-5.
- Individual participant dataSharing planned: Undecided
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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.
Julia C. Stingl, MD, ScD principal investigator
Institute of Clinical Pharmacology, University Hospital RWTH Aachen
Questions about this trial
What is this clinical trial studying?
An observational study of Polypharmacy and Pharmacogenetics, run by RWTH Aachen University.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathias Freitag (+492417501116 ext. +492418089134, mfreitag@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of vulnerability profiles of adverse drug reactions (time frame: February 2022 - February 2032). 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 NCT05247814, 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 23 Jun 2022.