Unique ID issued by UMIN | UMIN000037358 |
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Receipt number | R000042581 |
Scientific Title | Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension |
Date of disclosure of the study information | 2019/08/01 |
Last modified on | 2023/01/14 10:12:08 |
Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension
Impact of Esaxerenone on Left Ventricular Diastolic Function
Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension
Impact of Esaxerenone on Left Ventricular Diastolic Function
Japan |
Chronic heart failure patients with hypertension
Cardiology |
Others
NO
The aim of this study is to investigate the effect of esaxerenone on left ventricular diastolic function in chronic heart failure patients with hypertension
Efficacy
A change in E/e' between baseline and 6 months after the start of administration
of esaxerenone.
A change in brain natriuretic peptide (BNP), left atrial volume index, left venrtricular mass index between baseline and 6 months after the start of administration of esaxerenone.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
1
Treatment
Medicine |
administration of esaxerenone
20 | years-old | <= |
100 | years-old | > |
Male and Female
(1) Patients with hypertension (systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg)
(2) Patients with chronic heart failure (NYHA functional classification I-III)
(3) NYHA functional classification and receiving cardio-protective drugs such as ACE inhibitors, ARBs, or beta-blockers has been stable for 4 weeks from enrollment
(1) New onset of acute coronary syndrome, cerebrovascular diseases, myocarditis, constructive pericarditis, severe valvular heart diseases within 3 months.
(2) New onset of atrial fibrillation or atrial flutter within 3 months
(3) Severe kidney disease (eGFR less than 30 mL/min/1.73 m2 or dialysis patients)
(4) Patients with hyperkalemia or serum potassium level>5.0mEq/L at enrollment
(5) Patients erceiving potassium-conserving diuretics, mineralocorticoid receptor antagonists, potassium preparations
(6) Cancer patients
(7) Pregnant women, lactating woman or women who wish to a pregnancy
100
1st name | Hidekazu |
Middle name | |
Last name | Tanaka |
Kobe University Graduate School of Medicine
Division of Cardiovascular Medicine, Department of Internal Medicine
650-0017
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
078-382-5846
tanakah@med.kobe-u.ac.jp
1st name | Hidekazu |
Middle name | |
Last name | Tanaka |
Kobe University Graduate School of Medicine
Division of Cardiovascular Medicine, Department of Internal Medicine
650-0017
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
078-382-5846
tanakah@med.kobe-u.ac.jp
Kobe University Graduate School of Medicine
None
Other
Kobe University Hospital Clinical & Translational Reserch Center
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
078-382-6669
cerb@med.kobe-u.ac.jp
NO
2019 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2019 | Year | 07 | Month | 12 | Day |
2021 | Year | 11 | Month | 04 | Day |
2019 | Year | 08 | Month | 01 | Day |
2022 | Year | 02 | Month | 28 | Day |
2019 | Year | 07 | Month | 13 | Day |
2023 | Year | 01 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042581
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