Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure
COMPLIANCE
1 other identifier
observational
72
1 country
1
Brief Summary
The aim of this prospective cohort study is to assess the adherenсe to medical therapy and its influence on long-term outcomes in patients with chronic heart failure in the outpatient registry
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 15, 2022
November 1, 2022
1 year
February 7, 2020
November 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to life-modifying treatment
The Adherence scale of the Russian National Society of evidence based pharmacotherapy will be used to assess patients' adherence to treatment. The patients will be asked questions about taking prescribed medications as recommended by a doctor. The score system with the min value in the scale 0 and the max value 4 is used for the assessment of the results: 0 - adherent, 1-2 - partially adherent, 3 - partially non-adherent, 4 - non adherent.
1 year
Secondary Outcomes (5)
Death
1 year
Chronic heart failure decompensation with hospitalization
1 year
Chronic heart failure decompensation without hospitalization
1 year
Myocardial Infarction
1 year
Unplanned hospitalization for Cardiovascular disease
1 year
Eligibility Criteria
All patients with documented HF having consequentially come for consultation to the specialized cardiology department of the scientific research center from Junuary 1, 2016 to July 31, 2020 (Included in the registry PROFILE)
You may qualify if:
- All patients with documented Сhronic heart failure who were included in register PROFILE from from Junuary 1, 2016 to July 31, 2020
- Ejection fraction \<50% or
- Ejection fraction ≥ 50% plus increase of BNP\>500 ng/l or NT-proBNP \<50 years - 450 ng/l , 50-75 years \> 900 ng/l; \>75years \> 1800 ng/l
You may not qualify if:
- Patients whose life status is defined as "dead"
- Patients who refused to participate in our study
- Refusal to sign informed agreement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
Moscow, 101990, Russia
Related Publications (1)
Martsevich SY, Lukina YV, Kutishenko NP, Guseynova ET. 0Effects of the COVID-19 Pandemic on Treatment Adherence in Patients with Chronic Heart Failure. Caspian J Intern Med. 2022;13(Suppl 3):199-203. doi: 10.22088/cjim.13.0.199.
PMID: 35872693DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sergey Martsevich, PhD
National Research Center for Preventive Medicine
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
February 7, 2020
First Posted
February 10, 2020
Study Start
December 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share