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OpenTrials
Completed

NCT Number: NCT03455439

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)

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.

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

As prescribed by the treating physician

Primary outcomes

  1. 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

  1. Date of death

    Time frame: Up to 24 months or early termination

  2. Date of all hospitalizations or admissions to emergency service

    Time frame: Up to 24 months or early termination

    due to a HF exacerbation or all cause

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Acronym: FARAONIC

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 6, 2018
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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