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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 101990
    • Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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)

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients whose life status is defined as "dead"
• Patients who refused to participate in our study
• Refusal to sign informed agreement

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Total number - of all events	1 year
Chronic heart failure decompensation with hospitalization	Total number - of all events	1 year
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
Myocardial Infarction	Total number - of all events	1 year
Unplanned hospitalization for Cardiovascular disease	Total number - of all events	1 year

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Investigators: Study Chair: Sergey Martsevich, PhD, National Research Center for Preventive Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Heart Failure, adherence, registry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 09062019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No