check_circleStudy 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
  • - 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.
  • - 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
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Spain

Primary Outcome

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

Secondary Outcome

  • Date of death
    date_rangeTime 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
    date_rangeTime 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

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.