Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)

Bayer1 site in 1 country552 target enrollmentMarch 16, 2018

ConditionsHeart Failure

InterventionsRivaroxaban (Xarelto, BAY59-7939)

DrugsRivaroxaban (Xarelto, BAY59-7939)

Overview

Phase: Not Applicable
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Heart Failure
Sponsor: Bayer
Enrollment: 552
Locations: 1
Primary Endpoint: Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluation of the risk factors associated with Heart Failure (HF) worsening (measured by hospitalizations and emergency visits because of HF exacerbations) in Spanish patients with Atrial Fibrilation and HF treated with rivaroxaban.

Registry

clinicaltrials.gov

Start Date

March 16, 2018

End Date

January 11, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult males and females aged 18 years or older.
•Patients with a diagnosis of nonvalvular Atrial Fibrilation (AF).
•Patients with a diagnosis of chronic Heart Failure, New York Heart Association (NYHA) class I-IV HF with preserved Ejection Fraction (HFpEF), HF with reduced EF (HFrEF) or HF with mid-range EF (HFmrEF).
•Patients receiving antithrombotic treatment because of AF, with rivaroxaban since at least 4 months before entering the study.
•Patients who have been given appropriate information about the study objectives and procedures and with the mental and physical capacity to give their informed consent to participate in the study.

Exclusion Criteria

•Patients participating in a research program which involves some intervention beyond clinical practice.
•Patients who started rivaroxaban after the start of the inclusion period.
•Patients with significate mitral stenosis or other heart valvular diseases that requires or have needed specific treatment (prosthesis or valvuloplasty).
•Patients with severe cognitive impairment.

Arms & Interventions

Rivaroxaban

Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Outcomes

Primary Outcomes

Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation

Time Frame: Up to 24 months or early termination

Secondary Outcomes

Date of death(Up to 24 months or early termination)
Date of all hospitalizations or admissions to emergency service(Up to 24 months or early termination)