NCT02790801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

May 31, 2016

Last Update Submit

August 1, 2017

Conditions

Chronic Heart FailureAtrial Fibrillation

Keywords

chronic heart failureatrial fibrillationanticoagulant

Outcome Measures

Primary Outcomes (1)

  • 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

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.

    Day 1 up to approximately 12 months

  • All-cause mortality. Death due to any cause.

    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

    1 year

Study Arms (1)

1 group

observation of patients with chronic heart failure and atrial fibrillation

Other: observation

Interventions

observationOTHER

observation

1 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from primary care clinics, hospilals

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • any severe condition limiting life less than 3 months
  • HIV infection
  • Alcohol consumption or psychoactive drugs intake
  • patient is not ready to contact by telephone at the end of the study at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSSICardiology

Moscow, 121552, Russia

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Observation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Sergey N Tereshchenko, Prof

    Federal State Budgetary Scientific Institution, Research Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 6, 2016

Study Start

February 1, 2015

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

August 2, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)