{
  "abstract": "Introduction 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",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, Gunma University Graduate School of Medicine, Maebashi, Japan"
      ],
      "name": "Kazuki Kagami"
    },
    {
      "affiliations": [
        "Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan"
      ],
      "name": "Toru Kondo"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, Shinshu University School of Medicine, Matsumoto, Japan"
      ],
      "name": "Sho Suzuki"
    },
    {
      "affiliations": [
        "Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan"
      ],
      "name": "Yuki Saito"
    },
    {
      "affiliations": [
        "Department of Cardiovascular and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan"
      ],
      "name": "Shinya Fujiki"
    },
    {
      "affiliations": [
        "Department of Cardiology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan"
      ],
      "name": "Shinya Takahashi"
    },
    {
      "affiliations": [
        "Division of Cardiology, Teine Keijinkai Hospital, Sapporo, Japan"
      ],
      "name": "Hiroyuki Iwano"
    },
    {
      "affiliations": [
        "Department of Cardiology, Hokkaido Cardiovascular Hospital, Sapporo, Japan"
      ],
      "name": "Kazunori Omote"
    },
    {
      "affiliations": [
        "Department of Cardiology, Saitama Medical Center, Kawagoe, Japan"
      ],
      "name": "Kentaro Jujo"
    },
    {
      "affiliations": [
        "Department of Cardiology, National Defense Medical College, Tokorozawa, Japan"
      ],
      "name": "Yuji Nagatomo"
    },
    {
      "affiliations": [
        "Cardiovascular Division, National Hospital Organization Osaka National Hospital, Osaka, Japan"
      ],
      "name": "Haruhiko Abe"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine and Endocrinology and Metabolism, Faculty of Medicine, Tottori University, Yonago, Japan"
      ],
      "name": "Yoshiharu Kinugasa"
    },
    {
      "affiliations": [
        "Division of Cardiology, Shimane University Faculty of Medicine, Izumo, Japan"
      ],
      "name": "Junya Tanabe"
    },
    {
      "affiliations": [
        "Division of Cardiology, Shimane University Faculty of Medicine, Izumo, Japan",
        "Department of Internal Medicine, Izumo City General Hospital, Izumo, Japan"
      ],
      "name": "Takahiro Sakamoto"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Gunma University Graduate School of Medicine, Maebashi, Japan"
      ],
      "name": "Takuya Araki"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, Shinshu University School of Medicine, Matsumoto, Japan"
      ],
      "name": "Masatoshi Minamisawa"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, Gunma University Graduate School of Medicine, Maebashi, Japan"
      ],
      "name": "Hideki Ishii"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, Gunma University Graduate School of Medicine, Maebashi, Japan"
      ],
      "name": "Masaru Obokata"
    }
  ],
  "title": "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",
  "uid": "75a48cfd-a0a8-51ee-a61d-54a2b75054c0"
}