Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT03455439
Start Date
March 16 2018
End Date
January 11 2022
Last Update
November 7 2023
Active Locations (1)
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1
Many Locations
Multiple Locations, Spain