Study Completed

Heart Failure

Bayer Identifier:

19584

ClinicalTrials.gov Identifier:

NCT03455439

EudraCT Number:

Not Available

EU CT Number:

Not Available

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 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.

Key Participants Requirements

Sex

All

Age

18 - N/A

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

552

Trial Dates

March 2018 - January 2022

Phase

Phase 4

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Spain

Primary Outcome

Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation
Time Frame:
Up to 24 months or early termination

Secondary Outcome

Date of death
Time Frame:
Up to 24 months or early termination
Date of all hospitalizations or admissions to emergency service
due to a HF exacerbation or all cause
Time Frame:
Up to 24 months or early termination

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

N/A

Additional Information

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