NCT02790801

The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Federal State Budgetary Scientific Institution, Research Institute of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Chronic Heart Failure
• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	observation	observation

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2016-06-06
• Last updated: 2017-08-02

Locations

1 site across 1 country: Russia