FARAONIC: 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)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rivaroxaban Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | Spain |
Sponsors and Collaborators
- Bayer
- Janssen Research & Development, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19584