COMPLIANCE: Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure
Study Details
Study Description
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
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Detailed Description
Registry PROFILE is a patients database with cardiovascular diseases who consistently apply to the specialized cardiology department of the "National Medical Research Center for Preventive Medicine" for consultation or to assess their possible participation in clinical trials The purpose of this study is to assess adherence to medical therapy and its impact on long-term outcomes in patients with chronic heart failure enrolled to PROFILE registry from 01 January 2016 to 01 July 2020. The patients who were enrolled between 01 January 2016 to 01 December 2019 will be invited to clinical visit by phone. For patients who will join PROFILE registry after 01 December 2019 the first visit of this study is the day of enrollment to PROFILE registry.
The first visit (V1) is an inclusion in the study. During this visit assess adherence to medication therapy General and to specific medications. The main factors affecting treatment adherence will be identified.
The second visit (V2) is planned for each patient 1 year after the first visit (V2). During the second visit the adherence to the therapy and frequency of Secondary Outcome Measures will be estimated. Impossible to visit repeated, a telephone interview can be done
Study Design
Outcome Measures
Primary Outcome Measures
- Adherence to life-modifying treatment [1 year]
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.
Secondary Outcome Measures
- Death [1 year]
Total number - of all events
- Chronic heart failure decompensation with hospitalization [1 year]
Total number - of all events
- Chronic heart failure decompensation without hospitalization [1 year]
- onset of new symptoms (example:. Cardiac asthma, orthopnea- if you haven't registered before); -- increase in NYHA ≥1;- increase dose of diuretic
- Myocardial Infarction [1 year]
Total number - of all events
- Unplanned hospitalization for Cardiovascular disease [1 year]
Total number - of all events
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients with documented Сhronic heart failure who were included in register PROFILE from from Junuary 1, 2016 to July 31, 2020
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Ejection fraction <50% or
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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
Exclusion Criteria:
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Patients whose life status is defined as "dead"
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Patients who refused to participate in our study
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Refusal to sign informed agreement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation | Moscow | Russian Federation | 101990 |
Sponsors and Collaborators
- National Research Center for Preventive Medicine
Investigators
- Study Chair: Sergey Martsevich, PhD, National Research Center for Preventive Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09062019