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NCT Number: NCT07640854

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF) Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Medical Research Centre for Therapy and Preventive Medicine

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a confirmed diagnosis of chronic heart failure with reduced or mildly reduced ejection fraction (HFrEF / HFmrEF).
  • Diagnosis of HFrEF or HFmrEF confirmed by echocardiography within 3 months prior to enrollment.
  • Signed informed consent.

Exclusion criteria

  • Documented mental disorders.
  • Severe cognitive impairment

Treatment and study plan

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 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 outcomes

  1. Medication adherence assessed by the National Society of Evidence-Based Pharmacotherapy Scale

    Time frame: 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

  2. Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 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.

  3. Health literacy level assessed by a specialized screening tool

    Time frame: 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)

  4. Response validity score assessed by the Modified Express Module

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Registry information

Official study title

Prospective Observational Study of Polypharmacy, Safety, and Medication Adherence in Patients With HFrEF and HFmrEF: Data From the FARAON Registry

Acronym: FARAON

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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