Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)FARAONNCT07640854
Polypharmacy, Safety, and Medication Adherence in Patients With Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction
An observational study of Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF), run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jan 2026to Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Documented mental disorders.
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Centre for Therapy and Preventive Medicine
Moscow
About this study
Official title: Prospective Observational Study of Polypharmacy, Safety, and Medication Adherence in Patients With HFrEF and HFmrEF: Data From the FARAON Registry
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.
Read the 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.
- Conditions
- Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)
- 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
- Medical subject headings
- Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
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
Measured: 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.
Measured: 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)
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start20 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Martsevich, M.D., Professor, Study director, National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640854
- Sponsor's protocol ID
- 09-08/25
- Acronym
- FARAON
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Polypharmacy, Safety, and Medication Adherence in Patients With HFrEF and HFmrEF: Data From the FARAON Registry
- ClinicalTrials.gov ID
- NCT07640854
- Acronym / sponsor ID
- FARAON / 09-08/25
- Conditions
- Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)
- Keywords
- polypharmacy safety, health literacy, false compliance, declarative adherence, hidden non-adherence, polypragmasy, multimorbidity, adherence to treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Documented mental disorders.
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Medication adherence assessed by the National Society of Evidence-Based Pharmacotherapy Scale
Time frame: Baseline, 3 months, 6 months, and 12 months
Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline and 12 months
Health literacy level assessed by a specialized screening tool
Time frame: Baseline
Response validity score assessed by the Modified Express Module
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF)
Not yet recruitingObservational study
Precision Subtyping and Prognostic Study of Heart Failure Based on Multi-Omics Integration and Clinical Indicators: A Prospective Single-Center Cohort Study
Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Martsevich, M.D., Professor study director
National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure With Reduced and Mildly Reduced Ejection Fraction (HFrEF and HFmrEF), run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.