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)

Heart Failure Clinical Trial

— FARAONIC  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455439
• Other study ID #: 19584
• Status: Completed
• Start date: March 16, 2018
• Est. completion date: January 11, 2022

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: January 11, 2022
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Disease Progression
• Heart Failure

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician

Locations

Country	Name	City	State
Spain	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Gomez Doblas JJ, Cepeda-Rodrigo JM, Agra Bermejo R, Blanco Labrador E, Blasco MT, Carrera Izquierdo M, Lekuona I, Recio Mayoral A, Rafols C, Manito N. Outcomes and factors associated with mortality in patients with atrial fibrillation and heart failure: FARAONIC study. Clin Cardiol. 2023 Aug 18. doi: 10.1002/clc.24106. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Date of death		Up to 24 months or early termination
Secondary	Date of all hospitalizations or admissions to emergency service	due to a HF exacerbation or all cause	Up to 24 months or early termination

External Links

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