Heart failure with left ventricular diastolic dysfunction complicating hypertension
Conditions
Interventions
Azilsartan group Administration of 20 mg azilsartan once daily Patients who have already received azilsartan should continue the same dose at the time of consent. Patients who have received other
30) Patients who have already received candesartan should continue the same dose at the time of consent. Patients who have received other ARB medications should be administered the ARB-equivalent d
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20-85 years of age at consent 2) Patients with hypertension within 3 months from the date of obtaining consent Patients who satisfy any of the following conditions are considered hypertensive: 1. Patients with newly-diagnosed hypertension 2. Untreated patients with hypertension 3. Patients receiving an antihypertensive for hypertension 3) BNP levels >= 40 pg/mL or NT-proBNP levels >= 125 pg/mL, at least once within 4 months prior to the date of obtaining consent 4) Patients with heart failure Patients who satisfy any of the following conditions are considered heart failure: 1. Patients being hospitalized for heart failure 2. Patients with history of hospitalization for heart failure 3. NYHA functional classification >= II 5) Patients whose left ventricular ejection fraction >= 45% assessed by echocardiography within 4 months from the date of consent 6) Patients with left ventricular diastolic function ( E/e' >= 8) assessed by echocardiography 7) provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with history of adverse reactions including hyperkalemia or severe renal dysfunction by receiving ARB before consent 2) Patients receiving ACE inhibitor at consent 3) Patients with persistent atrial fibrillation at consent (not including a history of treatment for atrial fibrillation or presence of paroxysmal atrial fibrillation) 4) Systolic blood pressure remains continuously < 90 mmHg 5) Using mechanical ventricular assist device 6) Waiting for heart transplantation 7) Waiting for cardiac surgery 8) Patients with valvular heart disease at a moderate level or higher (except for moderate functional mitral regurgitation) 9) Patients underwent mitral valve replacement or mitral annuloplasty 10) Patients underwent constrictive pericarditis 11) Patients with a definitive diagnosis of hypertrophic cardiomyopathy 12) Patients with hyperkalemia at screening (equal or higher than 5.5 mEq/l) 13) Patients with serious renal dysfunction (eGFR < 15 mL/min/1.73 m2) at screening 14) Patients with hepatic dysfunction (elevation in AST/ALT levels 3 times greater than the upper limit of normal) at screening (When the elevation is attributable to the heart disease, the patient is eligible if the total bilirubin level is less than 3.0 mg/dL) 15) Patients with a history of hospitalization for cerebrovascular disorder within 6 months before consent 16) Patients with bilateral renal artery stenosis or patients who have only one kidney with artery stenosis 17) Patients with history of hypersensitivity to drug 18) Patients who have less than 3 years of life expectancy due to serious disease 19) Patients suspected of alcohol or drug abuse 20) Patients with diabetes receiving aliskiren fumarate 21) Pregnant or possibility of pregnancy 22) Patients who are participating in another study (except for observational research) 23) Patients considered ineligible to participate in this study by principal (sub) investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in E/e' assessed by echocardiography (from baseline to the end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation for LV diastolic function improvement assessed by echocardiography except for E/e' change The change in 1) e' from baseline (at the end of the study) 2) E/A from baseline (at the end of the study) 3) deceleration time of E from baseline (at the end of the study) 4) LAD from baseline (at the end of the study) Evaluation for cardiac structure, systolic and diastolic function assessed by echocardiography 5) LVDd, LVDs, LAVI, and LAD 6) LVEF from baseline (at the end of the study) 7) LVMI from baseline (at the end of the study) 8) the end-systolic elastance and end-diastolic elastance of the LV from baseline (at the end of the study) Evaluation for heart failure severity 9) NYHA functional classification from baseline (24-week post drug administration and the end of the study) 10) NT-proBNP levels from baseline (4-week post drug administration and the end of the study) 11) serum aldosteron levels from baseline (at the end of the study) Evaluation for antihypertensive effect 12) systolic and diastolic blood pressure from baseline (4, 12, 24, 36-week post drug administration and at the end of the study) Evaluation for cardiovascular event The incidence of 13) composite end point (death from cardiovascular disease or hospitalization for cardiovascular disease) at the end of the study 14) composite end point (death from cardiovascular disease or hospitalization for heart failure) at the end of the study 15) death from cardiovascular disease (at the end of the study) 16) hospitalization for cardiovascular disease (at the end of the study) 17) hospitalization for heart failure (at the end of the study) 18) death from any cause (at the end of the study) 19) hospitalization for any cause (at the end of the study) 20) additional therapy or dose escalation for heart failure caused by worsening of heart failure (24-week post drug administration and the end of the study) 21) onset of new atrial fibrillation/flutter ( | — |
Countries
Japan
Contacts
Public ContactShin Ito
National Cerebral and Cardiovascular Center Department of Cardiovascular Medicine
Outcome results
None listed