Heart failure with atrial fibrillation
Conditions
Interventions
Treatment will be started with 15 mg of rivaroxaban. If the patient represents a lower creatinine clearance of 30 - 49 minutes, treatment will be deceased to 10 mg. The patients in this group will be
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: from 20 years old, less than 85 years old. 2) Diagnosis of heart failure. (The patients with heart failure is defined if following either criteria is fullfilled: 2-1: hospitalizing patients due to heart failure, 2-2: patients who has history of heart failure hospitalization, 2-3: representing both heart failure symptom (>=NYHA 2) and plasma BNP levels>=100pg/ml within 6months. 3) paroxymal atrial fibrillation or consistent atrial fibrillation. 4) obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) the patients currently receving novel anti-coaglants) 2) the patients with intraventricular thrombus 3) the patients with moderate or severe valvular heart disease 4) the patients requiring mechanical circulatory support 5) the patients waiting for cardiovascular surgery 6) the patients with infective disease or autoimmune disease, or receving steroid 7) the patients with cardiac sarcoidosis 8) the patients who start to receive statin or acetylsaliccylic acid 9) the paients who occurred myocardial infarction or stroke or systemic embolism. 10) the patients who represent creatnine clearance 15ml/min 11) liver cirrhosis, Child B or C 12) intracranial hemorrhage or gastrointenstinal bleeding within 6 months 13) pregnant women 14) the patients receiving cobicistat or HIV protease 15) the patients receiving azole antifungal agents 16) the patiens with warfarin or ribaroxaban sensitivity 17) the patients receiving menatetrenone 18) the patients receiving iguratimod 19) the patiens with advanced cancer 20) the patiens who are participating other prospective clinical trials 21) The physician judge to be unsuitable for the enrollment to this study due to any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in high sensitive CRP during the treatments (after 12 weeks, 48 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in plasma levels of pentraxin 3 (Baseline vs. treatment after 3months) 2) Changes in plasma levels of GDF15 (Baseline vs. treatment after 3months) 3) Changes in plasma levels of matrix gla protein (Baseline vs. treatment after 3months) 4) Changes in plasma levels of thrombin-antithrombin complex (Baseline vs. treatment after 3months) 5) Changes in plasma levels of prothrombin fragment 1+2 (Baseline vs. treatment after 3months) 6) Changes in plasma levels of BNP (Baseline vs. treatment after 3months) 7) Occurrences of combined clinical events (either cardiovascular death or hospitalization due to cardiovascular disease) 8) Occurrences of combined clinical events (either cardiovascular death or hospitalization due to heart failure) 9) Occurrences of cardiovascular death 10) Occurrences of hospitalization due to cardiovascular disease 11) Occurrences of cardiovascular death due to heart failure 12) all causes of death 13) all causes of hospitalization 14) Occurrences of hospitalization due to stroke 15) Occurrences of intracardiac thrombus | — |
Countries
Japan
Contacts
Public ContactHiroyuki Takahama
National Cerebral and Cardiovascular Center Department of cardiovascular medicine
Outcome results
None listed