Acute Heart Failure
Conditions
Brief summary
Vitamin K antagonists (VKAs) are used to reduce the risk of stroke (cerebral vascular dysfunction) in AF patients. However, VKAs interact with drugs/food and the drug level is influenced by worsening of renal function, liver congestion or hemodynamic alterations in acute decompensated heart failure (ADHF). New oral anticoagulants (rivaroxaban, apixaban, dabigatran) are alternatives to VKA, such as warfarin. In post hoc analysis of ROCKET AF trial, 63.7% patients had HF and treatment-related outcomes were similar in patients with and without HF (Circulation HF. 2013; 6:740-7). So rivaroxaban 20 mg daily (or 15 mg daily in patients with creatinine clearance 30-49 mL/min) was safe in nonvalvular AF patients with HF. However, the clinical effect and safety of rivaroxaban were largely unknown in acute decompensated heart failure (ADHF) patients with atrial fibrillation (AF). ROAD HF-AF is the exploratory study to assess the change of surrogate markers (hsTn, d-dimer) when treated with rivaroxaban vs. warfarin and to strengthen the basis for future biomarker-based therapy in ADHF patients
Interventions
DRUGRivaroxaban
Rivaroxaban 20mg qd (15mg qd when CrCl 30-49 ml/min using creatinine-based CKD-EPI equations) for 6 months
DRUGWarfarin + LMWH
dose-adjusted warfarin (target INR 2-3) for 6 months + LMWH (enoxaparin 1 mg/kg q12h for a few days until INR target achieved) if indicated
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
warfarin vs. rivaroxaban
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hospitalized patients with a primary diagnosis of ADHF with AF One of the following criteria and LVEF ≤ 40% (at least 1 year before admission or admission) 1. dyspnea at rest 2. tachypnea; a respiratory rate \> 20/min 3. rales 4. pulmonary edema on chest X-ray
Exclusion criteria
1. History of increased bleeding risk (like ROCKET AF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of high sensitive troponin | Baseline to 72 hours | The maximum hsTn value change from baseline to during hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6) all-cause mortality | 6) 6 months after hospitalization | 6\) Incidence proportion of in-hospital all-cause death cases |
| 1) the change of hish sensitive troponin | 1) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge | 1\) The change from baseline in hsTn on Day2, day4, day7 (or discharge), and follow-up visits at 1 month, 6 months |
| 2) the change of D-dimer | 2) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge | 2\) D-dimer change from baseline during hospitalization (day2, day4, day7 or discharge) & follow-up visits at 1, 6 months |
| 7) all-cause hospitalization & mortality | 7) 6 months after hospitalization | 7\) Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization |
| 4) bleeding event | 4) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/3month/6month after discharge | 4\) Incidence proportion and rate of major/minor bleeding during the study |
| 5) hospital stay | 5) The duration of hospital stay, average 7 days | 5\) Length of hospital stay |
| 3) the change of NT-proBNP | 3) On admission, hospital day #7 or discharge, 1 month/6month after discharge | 3\) TAT complex, PAI-1, hsCRP, NT-proBNP, sST2, galectin-3, cystatin C, NGAL, NAG change from baseline to day7 or discharge & 1,6 months after discharge |
Countries
South Korea
Contacts
Primary ContactSeok-Min Kang, MD
Outcome results
None listed