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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 group | observation of patients with chronic heart failure and atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation | Other | observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to approximately 12 months | |
| All-cause mortality. Death due to any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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patients from primary care clinics, hospilals
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| Name | Affiliation | Role |
|---|---|---|
| Sergey N Tereshchenko, Prof | Federal State Budgetary Scientific Institution, Research Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSSICardiology | Moscow | 121552 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 1 year |
| Rate of thromboembolic events defined as ischemic stroke, system embolism, deep vein thrombosis, pulmonary embolism. | 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 | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |