Heart FailureCOMPLIANCENCT04262583
Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure
An observational study of Heart Failure, run by National Research Center for Preventive Medicine at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2019to 1 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Patients whose life status is defined as "dead"
- Patients who refused to participate in our study
- Refusal to sign informed agreement
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
Moscow, 101990
About this study
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
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
Read the 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
- Conditions
- Heart Failure
- Keywords
- Chronic Heart Failure, adherence, registry
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Death
Total number - of all events
Measured: 1 year
Chronic heart failure decompensation with hospitalization
Total number - of all events
Measured: 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
Measured: 1 year
Myocardial Infarction
Total number - of all events
Measured: 1 year
Unplanned hospitalization for Cardiovascular disease
Total number - of all events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Dec 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Martsevich, PhD, Study chair, National Research Center for Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262583
- Sponsor's protocol ID
- 09062019
- Acronym
- COMPLIANCE
- Status last verified
- Nov 2022
- First submitted
- 7 Feb 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35872693
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04262583
- Acronym / sponsor ID
- COMPLIANCE / 09062019
- Conditions
- Heart Failure
- Keywords
- Chronic Heart Failure, adherence, registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients whose life status is defined as "dead"
- Patients who refused to participate in our study
- Refusal to sign informed agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to life-modifying treatment
Time frame: 1 year
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.
5 secondary outcomes
Death
Time frame: 1 year
Chronic heart failure decompensation with hospitalization
Time frame: 1 year
Chronic heart failure decompensation without hospitalization
Time frame: 1 year
Myocardial Infarction
Time frame: 1 year
Unplanned hospitalization for Cardiovascular disease
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 35872693Martsevich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Martsevich, PhD study chair
National Research Center for Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by National Research Center for Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to life-modifying treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.