Helping adults taking five or more medicines stay safer

Empowering Patients to Improve Safety in Polymedication (EmPaSafe)

This project will test a patient-centered program that combines medication review and genetic testing to reduce harmful drug-drug and drug-gene interactions for adults on five or more medicines.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 4 sites (Aachen and 3 other locations)
• Trial ID: NCT06956820 on ClinicalTrials.gov

What this trial studies

The project develops a patient-centered framework to define, assess, and manage drug-drug, drug-gene, and combined drug-drug-gene interactions in people with polypharmacy. Eligible participants (age ≥18) who take five or more drugs and start at least one listed index medication provide blood or saliva for genotyping and receive support from a medication management center, with follow-up for at least 12 weeks. The multi-center effort at European university hospitals integrates pharmacogenetic results with systematic medication review to generate personalized recommendations and empower patients and their general practitioners to adjust regimens. Because large randomized trials are impractical for the full complexity of polypharmacy, the project uses real-world clinical data and targeted interventions to close knowledge gaps and produce practical guidance.

Who should consider this trial

Good fit: Adults aged 18 or older who are taking five or more medications, are starting at least one listed index drug, can provide a blood or saliva sample, have a fixed address and a general practitioner, and can be followed for 12 weeks.

Not a fit: People who are pregnant or breastfeeding, have a life expectancy under three months, lack a fixed address or GP, have already been genotyped for pharmacogenes, or have severe kidney failure (eGFR <15 ml/min) are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this approach could reduce adverse drug reactions and improve medication safety and adherence for people taking many medicines.

How similar studies have performed: Previous work shows pharmacogenetic testing and structured medication reviews can reduce some adverse events, but combining drug-drug and drug-gene interaction management in a patient-centered framework is relatively novel.

Eligibility criteria

In order to be eligible to participate in this study, a subject must meet all of the following crite-ria:

* Polypharmacy defined as the use of 5 or more drugs
* Start usage of at least one index drug according to the list in table 3.
* Subject must be ≥ 18 years old
* Subject is able and willing to take part and be followed-up for at least 12 weeks
* Subject is able to donate blood or saliva
* Subject has signed informed consent

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Pregnancy or lactating
* Life expectancy estimated to be less than three months by treating clinical team
* Unable to consent to the study
* Unwilling to take part
* Subject has no fixed address
* Subject has previously been genotyped for PGx genes
* Subject has no current general practitioner
* Subject is, in the opinion of the Investigator, not suitable to participate in the study
* Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1,73m2
* Patients with advanced liver failure (stage Child-Pugh C)

Where this trial is running

Aachen and 3 other locations

• Universitatsklinikum Aachen — Aachen, Germany (Recruiting)
• Universitatsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
• University Hospital Patras — Pátrai, Greece (Recruiting)
• University Hospital Ljubljana — Ljubjana, Slovenia (Recruiting)

Study contacts

• Study coordinator: Jesse J Swen

Conditions Polypharmacy