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This prospective registry study (FARAON) aims to assess the prevalence, structure, safety profile, and dynamics of polypharmacy, as well as its association with medication adherence, quality of life, and clinical outcomes in multimorbid patients with HFrEF and HFmrEF, aiming to identify potentially inappropriate prescribing (over/mis/underprescribing) and determine factors linked to low adherence and adverse events.
The proposed statistical analysis plan for validating the Modified Express Module focuses on comparing biomarker levels and echocardiographic data between patients with true and declarative adherence, using the two-step Spearman correlation analysis for construct validation. To secure intellectual property, the description emphasizes methodological steps-specifically, analyzing correlations before and after excluding high-lie-score patients-without disclosing the specific proprietary questionnaires used, masking them under functional terms.
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Composite clinical endpoint (MACE and emergency medical care): Incidence of all cause death, emergency hospitalization for heart failure decompensation, acute myocardial infarction, stroke, or emergency calls for underlying CHF | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence assessed by the National Society of Evidence-Based Pharmacotherapy Scale | Medication adherence will be assessed using the National Society of Evidence-Based Pharmacotherapy Scale. Scores range from 0 to 4 points, with lower scores indicating better treatment adherence | Baseline, 3 months, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study included patients with a confirmed diagnosis of chronic heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF), verified by echocardiography within 3 months before enrollment. All participants provided written informed consent. Patients with documented mental disorders or severe cognitive impairment were excluded
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Martsevich, M.D., Professor | National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Centre for Therapy and Preventive Medicine | Moscow | Russia |
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| Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) |
Quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100 points, with higher scores indicating better health status and quality of life. |
| Baseline and 12 months |
| Health literacy level assessed by a specialized screening tool | Score ranges from 1 to 5 points. Higher scores indicate lower health literacy and greater need for medical reading assistance (1 is never needs help, 5 is always needs help) | Baseline |
| Response validity score assessed by the Modified Express Module | Score ranges from 0 to 3 points. Higher scores indicate a greater tendency toward social desirability and declarative behavior (0-1 indicates true adherence/reliable reports, 2-3 indicates declarative adherence/high risk of overreporting compliance). | Baseline |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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