Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)
Conditions
Keywords
polypharmacy safety, health literacy, false compliance, declarative adherence, hidden non-adherence, polypragmasy, multimorbidity, adherence to treatment, chronic heart failure, drug therapy, safety of medicines
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Medical Research Center for Therapy and Preventive Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a confirmed diagnosis of chronic heart failure with reduced or mildly reduced ejection fraction (HFrEF / HFmrEF). 2. Diagnosis of HFrEF or HFmrEF confirmed by echocardiography within 3 months prior to enrollment. 3. Signed informed consent.
Exclusion criteria
1. Documented mental disorders. 2. Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence assessed by the National Society of Evidence-Based Pharmacotherapy Scale | Baseline, 3 months, 6 months, and 12 months | 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 |
| Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline and 12 months | 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. |
| Health literacy level assessed by a specialized screening tool | Baseline | 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) |
| Response validity score assessed by the Modified Express Module | Baseline | 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). |
Countries
Russia
Contacts
STUDY_DIRECTORSergey Martsevich, M.D., Professor
National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia
Outcome results
None listed