Hypertensive patients with cardiac diastolic dysfunction and preserved ejection fraction
Conditions
Interventions
Eplerenone (25-50mg/day) is added to baseline treatment. The dose is adjusted according to conditions of patients with judgement of the physician in charge. Treatment period is for two years. The targ
Sponsors
Graduate School of Medical Sciences, Kumamoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ejection Fraction>=50%(The modified simpson method in an echocardiography or Left ventriculography or MRI or RI) 2.High blood pressure with anti-hypertensives) 3.E/e'>=15, or 15>E/e'>=8 and BNP>=100pg/ml (Measurement of E/e' is preferred to use both interventricular septum and side wall, though use of only either one of them is also acceptable complying to the usual method of each institution) 4.No evidence of hospitalization due to heart failure in the past 6 months
Exclusion criteria
Exclusion criteria: 1.Patients with severe renal failure (Ccr<=50ml/mi. Kakuta Y et al. Clin Exp Nephrol. 2010,14(1):63-7.) 2.Serum potassium level is equal or more than 5.0 mEq/L 3.Patients with severe hepatic insufficiency (Child-Pugh Score class C) 4.Patients currently under treatment of Itraconazole, Ritonavir, or Nelfinavir. 5.Patients with hypertrophic obstructive cardiomyopathy, cardiac amyloidosis, cardiac sarcoidosis, connective tissue disease, or malignancy 6.Patients with evere valvular disease 7.Patients with secondary hypertension 8.Patients underwent operative treatment or coronary angioplasty in the past one month 9.Patients treated with eplerenone or spironolactone in the past three months 10.Women who are wising to be pregnant, or of childbearing potential 11.Patients whose physicians determined inadequate to participate the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Plasma levels of B-type natriuretic peptide (BNP) from baseline to 12 months of treatment (if BNP logarithmic transformation does not follow normal distribution, consider using percent changes in BNP from baseline to 12 months of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum biomarkers high-sensitive troponin T level, P3NP, hsCRP, Big-endothelin Urinary biomarkers urinary albumin, 8-OHdG Tissue Doppler Echocardiography findings E, e', E/e' A composite of hospitalization or death due to cardiovascular event and significant exacerbation of cardio- and cerebro-vascular diseases (at 12 and 24 months from enrollment). Relationship between onset of cardiovascular event and biomarkers (exploratory) | — |
Countries
Japan
Contacts
Public ContactMegumi Yamamuro
Graduate School of Medical Sciences, Kumamoto University Cardiovascular medicine
Outcome results
None listed