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Heart Failure Patients Registry

Heart Failure Patients Registry

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19990 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-21

Study Completion Date

2024-03-28

Brief Summary

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This study is a multicenter non-interventional observational prospective registry. This non-interventional study (NIS) does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation. The study will include only those patients who sign the informed consent form (ICF) after explanation of the study objectives and methods by the study physician.

Planned study population consists of 20 000 adult outpatients with HF. All patients with HF who signed an ICF will be included to this study. Planned number of study sites is 150 outpatient centers in about 50 regions (in order to describe characteristics of outpatients with HF in different regions in the most comprehensive way).

Expected inclusion period duration - 24 months OR reaching 20 000 patients, if this takes less than 24 months. Planned follow-up period duration for 1 patient is about 52 weeks (12 months), which includes 3 visits (visit 1 - inclusion; visit 2 - approximately 6 months after inclusion; visit 3 - approximately 12 months after inclusion)

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
3. Documented diagnosis of HF (according to Clinical Guidelines "Chronic Heart Failure", 2020, approved by MoH of RF) with typical symptoms/signs of HF consistent with I-IV functional classes of HF according to NYHA classification.

Exclusion Criteria

1. The absence of signed ICF;
2. The participation in any randomised controlled trial within 3 months before the inclusion in this study or during the participation in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers