Kyoto Aldosterone Blocker Upstream Therapy on Atrial Fibrillation Trial (KABUTO-AF Trial)
- Conditions
- Paroxysmal af with hypertension and implanted pacemakers
- Registration Number
- JPRN-UMIN000003974
- Lead Sponsor
- KPUM KABUTO-AF study investigators
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
Previous administration of eplerenone Low EF<40% Symptomatic heart failure (NYHA>II) Enlarged LAD>55mm Valvular disease requiring surgical operation chronic Af ACS<30 days Cardiogenic shock Contraindication for Eplerenone Intolerance to Eplerenone Scheduled Cardiac surgery within 1year Scheduled Catheter ablation within 1 year Symptomatic arterial hypotension Secondary hypertension ICD pacemaker program change for af suppression options pregnancy Chronic inflammatory disease Malignancy Severe infection Life expectancy<1years eGFR<40 Dialysis Severe Liver dysfunction Drug addiction Alcohol abuse Inability to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of documented Af burden (%) Number of documented Af attack during 6 months Progression to permanent Af
- Secondary Outcome Measures
Name Time Method 6-month major adverse cardiac and cerebral event (MACCE) rate All cause death, cardiac death, myocardial infarction, PCI and/or CABG, Stroke, CHF requiring hospitalization,, aorta&peripheral artery disease, hemodialysis CRP, WBC, fibrinogen, aldosterone, renin, BNP,