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Trial record 1 of 1 for:    NCT02790801
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The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation (RIF-CHF)

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ClinicalTrials.gov Identifier: NCT02790801
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sergey Tereschenko, MD,Phd,prof, Federal State Budgetary Scientific Institution, Research Institute of Cardiology

Tracking Information
First Submitted Date May 31, 2016
First Posted Date June 6, 2016
Last Update Posted Date August 2, 2017
Study Start Date February 2015
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2016)
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 ]
Original Primary Outcome Measures
 (submitted: June 3, 2016)
hospitalization because of acute decompensation of heart failure [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures
 (submitted: July 6, 2016)
  • 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 ]
    Day 1 up to approximately 12 months
Original Secondary Outcome Measures
 (submitted: June 3, 2016)
  • cardiovascular mortality [ Time Frame: one year ]
  • all cause mortality [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation
Official Title The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation
Brief 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients from primary care clinics, hospilals
Condition
  • Chronic Heart Failure
  • Atrial Fibrillation
Intervention Other: observation
observation
Study Groups/Cohorts 1 group
observation of patients with chronic heart failure and atrial fibrillation
Intervention: Other: observation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2016)
1000
Original Estimated Enrollment Same as current
Actual Study Completion Date May 31, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT02790801
Other Study ID Numbers RW52.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sergey Tereschenko, MD,Phd,prof, Federal State Budgetary Scientific Institution, Research Institute of Cardiology
Study Sponsor Federal State Budgetary Scientific Institution, Research Institute of Cardiology
Collaborators Pfizer
Investigators
Principal Investigator: Sergey N Tereshchenko, Prof Federal State Budgetary Scientific Institution, Research Institute of Cardiology
PRS Account Federal State Budgetary Scientific Institution, Research Institute of Cardiology
Verification Date August 2017