Paroxysmal af with hypertension and implanted pacemakers
Conditions
Interventions
eplerenone 50-100mg for 6-month
conventional medication without eplerenone for 6-month
Sponsors
KPUM KABUTO-AF study investigators
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: DDD pacemaker(Device implantation>210 days) Documented paroxysmal Af Af burden(>2% &<90%) High BP(130-139/85-89mmHg)and Hypertension(140=or</90=or< mmHg) Age>20-90years Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of documented Af burden (%) Number of documented Af attack during 6 months Progression to permanent Af | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, | — |
Countries
Japan
Contacts
Public ContactHiroaki Matsubara, Takeshi Shirayama
KPUM KABUTO-AF study investigators Kyoto Prefectural University of Medicine(KPUM), Dept of Cardiology
Outcome results
None listed