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)
FARAONIC
1 other identifier
observational
552
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2018
CompletedFirst Posted
Study publicly available on registry
March 6, 2018
CompletedStudy Start
First participant enrolled
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2022
CompletedNovember 7, 2023
November 1, 2023
3.3 years
February 4, 2018
November 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Rivaroxaban
Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion
Interventions
Eligibility Criteria
Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion that attend the Cardiology Units or Internal Medicine Units at Spanish hospitals and private clinics.
You may qualify if:
- 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.
You may not qualify if:
- Patients participating in a research program which involves some intervention beyond clinical practice.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Many Locations
Multiple Locations, Spain
Related 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 Nov;46(11):1390-1397. doi: 10.1002/clc.24106. Epub 2023 Aug 18.
PMID: 37596723BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2018
First Posted
March 6, 2018
Study Start
March 16, 2018
Primary Completion
July 17, 2021
Study Completion
January 11, 2022
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.