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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03455439

Acronym

FARAONIC

Enrollment

552

Registered

2018-03-06

Start date

2018-03-16

Completion date

2022-01-11

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

As prescribed by the treating physician

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation	Up to 24 months or early termination

Secondary

Measure	Time frame	Description
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	due to a HF exacerbation or all cause

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026