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

NCT07640854 | Active Not Recruiting

• 1 other identifier: 09-08/25
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

polypharmacy safety; lie scales; SILS; health literacy; false compliance; declarative adherence; hidden non-adherence; polypragmasy; multimorbidity; adherence to treatment; chronic heart failure; drug therapy; safety of medicines

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

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

  Baseline, 3 months, 6 months, and 12 months

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

  Baseline and 12 months

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

  Baseline

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

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Documented mental disorders.
• Severe cognitive impairment

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Centre for Therapy and Preventive Medicine

Moscow, Russia

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Sergey Martsevich, M.D., Professor

  National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 11, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)