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)

Completed

• Conditions: Heart Failure
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT03455439
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-06
• Study Start: 2018-03-16
• Primary Completion: 2021-07-17
• Study Completion: 2022-01-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Many Locations; 🇪🇸 Multiple Locations, Spain