Clinical trial NCT04262583: Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Chronic Heart Failure, adherence, registry
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2020-02-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to life-modifying treatment
timeFrame: 1 year
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Chronic heart failure decompensation with hospitalization
timeFrame: 1 year
measure: Chronic heart failure decompensation without hospitalization
timeFrame: 1 year
measure: Myocardial Infarction
timeFrame: 1 year
measure: Unplanned hospitalization for Cardiovascular disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
Study officials:
affiliation: National Research Center for Preventive Medicine
name: Sergey Martsevich, PhD
role: STUDY_CHAIR
References:
citation: 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.