Efficacy of a comprehensive medication management programme on medication adherence in patients with heart failure and polypharmacy (PERSEUS-HF): study protocol for a multicentre randomised controlled trial
Kazuki Kagami, Toru Kondo, Sho Suzuki, Yuki Saito, Shinya Fujiki, Shinya Takahashi, Hiroyuki Iwano, Kazunori Omote, Kentaro Jujo, Yuji Nagatomo, Haruhiko Abe, Yoshiharu Kinugasa, Junya Tanabe, Takahiro Sakamoto, Takuya Araki, Masatoshi Minamisawa, Hideki Ishii, Masaru ObokataIntroduction
Guideline-directed medical therapy (GDMT) has been demonstrated to reduce morbidity and mortality in patients with heart failure (HF). In addition to the need for GDMT, a large number of cardiovascular and non-cardiovascular medications are prescribed to patients with HF, especially the elderly, due to multiple comorbidities and chronic health conditions, such as chronic pain, musculoskeletal problems, insomnia or gastrointestinal issues. Polypharmacy may reduce adherence to GDMT and compromise its optimisation, potentially leading to worse clinical outcomes in patients with HF.
Methods and analysis
The Polypharmacy Evaluation for improving adherence, Regimen Simplification, Enhancement and Utilization of Standard therapy in Heart Failure (PERSEUS-HF) trial is a prospective, multicentre, randomised, open-label trial testing whether a comprehensive medication management programme (CMMP) improves medication adherence at 6 months compared with standard of care in patients with HF and polypharmacy (≥ five regular oral medications). Three hundred patients are randomly assigned to receive either a CMMP or standard of care in a 1:1 ratio. The CMMP incorporates deprescribing potentially inappropriate medications based on the established Beers Criteria, structured medication education and counselling, optimising GDMT, reducing dosing frequency, using polypill, transitioning to as-needed medication and using unit-dose packaging. The primary endpoint is the change in total Adherence Starts with Knowledge 20 score from baseline to 6 months. The PERSEUS-HF trial will evaluate the efficacy of CMMP in improving medication adherence in patients with HF and polypharmacy.
Ethics and dissemination
This study was approved by the Institutional Review Board of the Gunma University Hospital, with the participants’ hospitals approving the execution of the study (IRB2025-070).
Clinical trial registration
jRCT1030250606