Chronic Heart FailureRIF-CHFNCT02790801
The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation
An observational study of Chronic Heart Failure and Atrial Fibrillation, run by Federal State Budgetary Scientific Institution, Research Institute of Cardiology at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate the management of chronic heart failure patients with atrial fibrillation, to collect data on compliance with clinical guidelines and the prevalence of long-term anticoagulant therapy,complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Atrial Fibrillation
- What is being tested?
- observation
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2015to 31 May 2017
- 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: patients from primary care clinics, hospilals
Who may be able to join
- patient has symptomatic chronic heart failure diagnosed more than 3 months before enrolling, if ejection fraction of left ventricular is >40% - N terminal-pro-B-type natriuretic peptide should be ≥300 pg/ml or B-type natriuretic peptide ≥100 pg/ml.
- patient has non-valvular stable atrial fibrillation
Who cannot join
- transient ischemic attack within 3 days before inclusion,
- stroke during 14 days before inclusion,
- myocardial infarction within 14 days before inclusion,
- thromboembolic complications or thrombosis within 14 days before inclusion,
- heart failure because of valvular pathology,
- heart failure induced by infection agents or infiltrative diseases, alcohol consumption, use of psychoactive drugs; peripartal heart failure; transient conditions
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- planning heart transplantation
- implantation of biventricular pacemaker within 28 days before inclusion
- any severe condition limiting life less than 3 months
- HIV infection
- Alcohol consumption or psychoactive drugs intake
- participation in any experimental study within 30 days before inclusion
- patient is not ready to contact by telephone at the end of the study at screening
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the management of chronic heart failure patients with atrial fibrillation, to collect data on compliance with clinical guidelines and the prevalence of long-term anticoagulant therapy,complications. The results will be used to develop most rational therapeutic and diagnostic strategies to improve clinical outcomes of such patients.
Read the detailed description
Quality assurance plan: investigators are going to plan site monitoring every three months. Any audits are not planned Investigatirs will check all entered data into the registry with the predefined ranges. The database is protected against any inconsistency and incorrect entering by the strictly predefined range in all fields. Instead of that, data checks will be performed yearly.
During the site monitoring data verification of the transfer from source documents to the database will be performed.
Iiverstigators have data dictionary, which includes descriptions of each variable and, if relevant, normal ranges.
Investigators use standard local operation procedures for any activities during the registry (as patient recruitment, data collection and management, data analysis) and local authorities approve all of those procedures.
Investigators calculated the sample size for demonstration of hypothesis of the registry.
Descriptive analysis of the data will be reported using basic summary statistics. Results will be summarized for the whole group and for the diagnostic subgroups. P-values and confidence intervals will be 2-sided, and statistical significance will be declared at the 2-sided 0,05-level. For continuous variables mean values, standard deviations, 95% confidence intervals, median and lower and upper percentiles, as well as minimum and maximum values will be calculated.
Safety is assessed by reports of AEs with relation, seriousness, action taken, and outcome. AEs are summarized using the MedDRA coding system. Event rates for single AEs are calculated based on the total number of documented patients. AEs are categorized according to relation, seriousness and outcome.
- Conditions
- Chronic Heart Failure, Atrial Fibrillation
- Being tested
- observation
- Keywords
- chronic heart failure, atrial fibrillation, anticoagulant
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
| Study group | Role | What they receive |
|---|---|---|
| 1 group | observation of patients with chronic heart failure and atrial fibrillation Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hospitalization for worsening of heart failure. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment due to HF as the primary reason
Measured: Day 1 up to approximately 12 months
Secondary outcomes (4)
Death due to a cardiovascular cause. CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV.
Measured: Day 1 up to approximately 12 months
All-cause mortality. Death due to any cause.
Measured: 1 year
Rate of thromboembolic events defined as ischemic stroke, system embolism, deep vein thrombosis, pulmonary embolism.
Measured: Day 1 up to approximately 12 months
Bleeding rate. ISTH major or CRNM bleeding during the time the patient is taking the medicine which is 6 months
Day 1 up to approximately 12 months
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 posted6 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completion31 May 2017
- Study completion31 May 2017
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 Chronic 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
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution, Research Institute of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Sergey Tereschenko, MD,Phd,prof, Federal State Budgetary Scientific Institution, Research Institute of Cardiology
- Investigators
- Sergey N Tereshchenko, Prof, Principal investigator, Federal State Budgetary Scientific Institution, Research Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790801
- Sponsor's protocol ID
- RW52.1
- Acronym
- RIF-CHF
- Status last verified
- Aug 2017
- First submitted
- 31 May 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
S.N. Tereshchenko, I.V. Zhirov, N.V. Romanova, Yu.F. Osmolovskaya, S.P. Golitsyn. The first Russian register of patients with chronic heart failure and atrial fibrillation (RIF-CHF): study design.Pharmacother Cardiol 2015;11(6):577-581.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02790801
- Acronym / sponsor ID
- RIF-CHF / RW52.1
- Conditions
- Chronic Heart Failure, Atrial Fibrillation
- Keywords
- chronic heart failure, atrial fibrillation, anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific Institution, Research Institute of CardiologyUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2015
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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 purpose of this study is to evaluate the management of chronic heart failure patients with atrial fibrillation, to collect data on compliance with clinical guidelines and the prevalence of long-term anticoagulant therapy,complications. The results will be used to develop most rational therapeutic and diagnostic strategies to improve clinical outcomes of such patients.
Detailed description
Quality assurance plan: investigators are going to plan site monitoring every three months. Any audits are not planned Investigatirs will check all entered data into the registry with the predefined ranges. The database is protected against any inconsistency and incorrect entering by the strictly predefined range in all fields. Instead of that, data checks will be performed yearly.
During the site monitoring data verification of the transfer from source documents to the database will be performed.
Iiverstigators have data dictionary, which includes descriptions of each variable and, if relevant, normal ranges.
Investigators use standard local operation procedures for any activities during the registry (as patient recruitment, data collection and management, data analysis) and local authorities approve all of those procedures.
Investigators calculated the sample size for demonstration of hypothesis of the registry.
Descriptive analysis of the data will be reported using basic summary statistics. Results will be summarized for the whole group and for the diagnostic subgroups. P-values and confidence intervals will be 2-sided, and statistical significance will be declared at the 2-sided 0,05-level. For continuous variables mean values, standard deviations, 95% confidence intervals, median and lower and upper percentiles, as well as minimum and maximum values will be calculated.
Safety is assessed by reports of AEs with relation, seriousness, action taken, and outcome. AEs are summarized using the MedDRA coding system. Event rates for single AEs are calculated based on the total number of documented patients. AEs are categorized according to relation, seriousness and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group | – | Other: observationobservation of patients with chronic heart failure and atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from primary care clinics, hospilals
Key inclusion criteria (2 listed)
- patient has symptomatic chronic heart failure diagnosed more than 3 months before enrolling, if ejection fraction of left ventricular is >40% - N terminal-pro-B-type natriuretic peptide should be ≥300 pg/ml or B-type natriuretic peptide ≥100 pg/ml.
- patient has non-valvular stable atrial fibrillation
Key exclusion criteria (13 listed)
- transient ischemic attack within 3 days before inclusion,
- stroke during 14 days before inclusion,
- myocardial infarction within 14 days before inclusion,
- thromboembolic complications or thrombosis within 14 days before inclusion,
- heart failure because of valvular pathology,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationobservation | Other | 1 group |
Primary outcome
Number of patients with hospitalization for worsening of heart failure. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment due to HF as the primary reason
Time frame: Day 1 up to approximately 12 months
4 secondary outcomes
Death due to a cardiovascular cause. CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV.
Time frame: Day 1 up to approximately 12 months
All-cause mortality. Death due to any cause.
Time frame: 1 year
Rate of thromboembolic events defined as ischemic stroke, system embolism, deep vein thrombosis, pulmonary embolism.
Time frame: Day 1 up to approximately 12 months
Bleeding rate. ISTH major or CRNM bleeding during the time the patient is taking the medicine which is 6 months
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 2 Aug 2017.
- BackgroundS.N. Tereshchenko, I.V. Zhirov, N.V. Romanova, Yu.F. Osmolovskaya, S.P. Golitsyn. The first Russian register of patients with chronic heart failure and atrial fibrillation (RIF-CHF): study design.Pharmacother Cardiol 2015;11(6):577-581.
- 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 N Tereshchenko, Prof principal investigator
Federal State Budgetary Scientific Institution, Research Institute of Cardiology
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 Chronic Heart Failure and Atrial Fibrillation, run by Federal State Budgetary Scientific Institution, Research Institute of Cardiology 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 2 inclusion and 13 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 2 Aug 2017. 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?
Number of patients with hospitalization for worsening of heart failure. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment due to HF as the primary reason (time frame: Day 1 up to approximately 12 months). 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 NCT02790801, 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 2 Aug 2017.