Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure

Heart Failure Clinical Trial

— COMPLIANCE  

Official title:

Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Chronic Heart failurE in the Outpatient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262583
• Other study ID #: 09062019
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

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