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Polypharmacy Evaluation for improving adherence, Regimen Simplification, Enhancement and Utilization of Standard therapy in Heart Failure

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	heart faliure
Date of first enrollment	26/12/2025
Target sample size	300
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome

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

Secondary Outcome

1) Medication adherence rate for the most recent month (28 days) at 6 months 2) Occurrence of a >30% decline in eGFR at 6 months, or hyperkalemia (K >5.5 mEq/L or initiation of new potassium binders), or hypokalemia (K <3.0 mEq/L) at 6 months 3) Change in NT-proBNP at 6 months 4) Proportion with NT-proBNP increase >30% at 6 months 5) Change in GNRI at 6 months 6) All-cause mortality up to 12 months 7) Heart failure hospitalization or unscheduled visits requiring IV diuretics up to 12 months 8) Increase or initiation of diuretics other than cardiac protective drugs (GDMT) by 12 months 9) Composite event of heart failure hospitalization, unscheduled visits requiring IV diuretics, or increase/initiation of diuretics other than GDMT by 12 months 10) Hospitalization triggered by any of the following abnormalities within 12 months (fracture, fall, delirium/consciousness disturbance, cognitive decline, syncope, bleeding, infection, malnutrition/anorexia, electrolyte abnormality, blood glucose abnormality, renal impairment, hepatic impairment, drug allergy, constipation/intestinal obstruction, drug-induced movement disorder) 11) Medication adherence rate in the most recent month at 12 months 12) Change in ASK-20 score at 12 months 13) Decrease in eGFR by >30% or development of hyperkalemia/hypokalemia as of December 14) Change in NT-proBNP level at 12 months 15) Change in GNRI level at 12 months

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	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
Exclude criteria	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