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

NCT ID: NCT04262583

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergey Martsevich, PhD

Role: STUDY_CHAIR

National Research Center for Preventive Medicine

Locations

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

Moscow, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 35872693 (View on PubMed)

Other Identifiers

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09062019

Identifier Type: -

Identifier Source: org_study_id

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