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Polypharmacy Evaluation for improving adherence, Regimen Simplification, Enhancement and Utilization of Standard therapy in Heart Failure (PERSEUS-HF)

Polypharmacy Evaluation for improving adherence, Regimen Simplification, Enhancement and Utilization of Standard therapy in Heart Failure (PERSEUS-HF)

Obokata Masaru

Gunma University Hospital

3-39-15 Showa-machi, Maebashi, Gunma, Japan

obokata.masaru@gunma-u.ac.jp

Kagami Kazuki

Gunma University Hospital

3-39-15 Showa-machi, Maebashi, Gunma, Japan

+81-27-220-8145

mirror.1028k@gmail.com

Recruiting

Dec. 26, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1) Patients aged 18 years or older at the time of consent acquisition
2) Patients with heart failure
3) Patients taking five or more regular oral medications
4) Patients for whom written consent for study participation is obtained from the individual

1) Patients for whom the physician clinically determines that the ASK-20 is difficult to administer due to cognitive impairment
2) Patients with comorbid conditions other than heart failure whose prognosis is less than six months
3) Patients participating in other interventional trials
4) Other patients deemed ineligible by the physician's judgment

Both

heart faliure

This study implements a comprehensive medication management program for patients in the intervention group. This program consists of: 1) Reducing or discontinuing inappropriate medications, primarily PIMs; 2) Medication counseling (at baseline and after 2 or 4 months); 3) Reducing the number of daily doses; 4) Using combination medications; 5) Switching from regular to as-needed medications; 6) Unit-dose packaging; 7) Strengthening GDMT. No pharmaceuticals, medical devices, or medical supplies beyond those covered by insurance will be used.

heart failure, polypharmacy, elderly

Comprehensive medication management

D006333

D054539

Change in ASK-20 scores from baseline to 6 months post-intervention

1. Adherence rate over the most recent month (28 days) at 6 months
2. Changes in total barrier count from baseline to 6 months
3. Incidence of greater than or equal to 30% decline in eGFR, hyperkalemia (K greater than or equal to 5.5 mEq/L or initiation of a potassium binder), or hypokalemia (K <3.0 mEq/L) within 6 months
4. Changes in NT-proBNP levels from baseline to 6 months
5. Incidence of greater than 30% increase in NT-proBNP levels from baseline to 6 months
6. Changes in the GNRI from baseline to 6 months
7. All-cause mortality up to 12 months
8. Hospitalization for HF or unplanned visit requiring IV diuretics up to 12 months
9. Up-titration or initiation of loop diuretics up to 12 months
10. Composite endpoint of HF hospitalization, unplanned visit requiring IV diuretics, or up-titration or initiation of non-GDMT diuretics up to 12 months
11. Hospitalization up to 12 months caused by the following: fracture, fall, delirium/impaired consciousness, cognitive decline, syncope, bleeding, infection, malnutrition/appetite loss, electrolyte abnormalities, blood glucose abnormality, renal dysfunction, hepatic dysfunction, drug allergy, constipation/bowel obstruction, or drug-induced movement disorder
12. Adherence rate over the most recent month (28 days) at 12 months
13. Changes in the ASK-20 score from baseline to 12 months
14. Changes in total barrier count from baseline to 12 months
15. Incidence of greater than or equal to 30% decline in eGFR, hyperkalemia, or hypokalemia within 12 months
16. Changes in NT-proBNP levels from baseline to 12 months
17. Changes in the GNRI from baseline to 12 months
18. Identifying the optimal medication management strategy to maximize changes in ASK-20 using artificial intelligence

+81-27-220-8740

Dec. 24, 2025

Yes

The de-identified participant data may be made available upon reasonable request to the corresponding author. To ensure compliance with the Japanese Act on the Protection of Personal Information and local ethical guidelines, data sharing will be strictly subject to the approval of our IRB and the execution of a formal data use agreement. Access will only be granted to researchers who provide a methodologically sound research proposal.

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