Clinical trial NCT03455439: 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2018-03-06
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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.

Primary outcomes:
measure: Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation
timeFrame: Up to 24 months or early termination
Secondary outcomes:
measure: Date of death
timeFrame: Up to 24 months or early termination
measure: Date of all hospitalizations or admissions to emergency service
timeFrame: Up to 24 months or early termination
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
facility: Many Locations
Study officials:
References:
citation: 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.