Polypharmacy, Safety, and Medication Adherence in Patients With Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction

N/AActive Not RecruitingNCT07640854

National Medical Research Center for Therapy and Preventive Medicine130 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Medical Research Centre for Therapy and Preventive Medicine

Moscow, Russia

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: Baseline, 3 months, 6 months, and 12 months

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.

Time frame: Baseline and 12 months

Health literacy assessed by the Single Item Literacy Screener (SILS)

Health literacy will be assessed using the Single Item Literacy Screener (SILS). Scores range from 1 to 5 points, with higher scores indicating lower health literacy and a greater need for assistance when reading medical materials

Time frame: Baseline

Social desirability bias assessed by the Modified Express Module for Declarative Adherence Detection

Social desirability bias will be assessed using the Modified Express Module for Declarative Adherence Detection. Scores range from 0 to 3 points, with higher scores indicating greater social desirability bias and a higher likelihood of overreporting medication adherence. Scores of 0-1 suggest reliable self-reports, whereas scores of 2-3 indicate declarative adherence and possible overreporting of medication adherence

Time frame: Baseline