Heart Failure Clinical Trial
— COMPLIANCEOfficial title:
Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Chronic Heart failurE in the Outpatient Registry
NCT number | NCT04262583 |
Other study ID # | 09062019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | December 1, 2021 |
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
Status | Completed |
Enrollment | 72 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients with documented ?hronic 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 Exclusion Criteria: - Patients whose life status is defined as "dead" - Patients who refused to participate in our study - Refusal to sign informed agreement |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation | Moscow |
Lead Sponsor | Collaborator |
---|---|
National Research Center for Preventive Medicine |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Death | Total number - of all events | 1 year | |
Secondary | Chronic heart failure decompensation with hospitalization | Total number - of all events | 1 year | |
Secondary | Chronic heart failure decompensation without hospitalization | - onset of new symptoms (example:. Cardiac asthma, orthopnea- if you haven't registered before); -- increase in NYHA =1;- increase dose of diuretic | 1 year | |
Secondary | Myocardial Infarction | Total number - of all events | 1 year | |
Secondary | Unplanned hospitalization for Cardiovascular disease | Total number - of all events | 1 year |
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