Trial Condition(s):
Heart Failure
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)
Bayer Identifier:
19584
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbationTimeframe: Up to 24 months or early termination
Secondary Outcome
- Date of deathTimeframe: Up to 24 months or early termination
- Date of all hospitalizations or admissions to emergency servicedue to a HF exacerbation or all causeTimeframe: Up to 24 months or early termination
Additional Information
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