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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000037358 |
Receipt No. | 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 | 2019/07/13 |
Basic information | ||
Public title | Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension | |
Acronym | Impact of Esaxerenone on Left Ventricular Diastolic Function | |
Scientific Title | Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension | |
Scientific Title:Acronym | Impact of Esaxerenone on Left Ventricular Diastolic Function | |
Region |
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Condition | ||
Condition | Chronic heart failure patients with hypertension | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to investigate the effect of esaxerenone on left ventricular diastolic function in chronic heart failure patients with hypertension |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | A change in E/e' between baseline and 6 months after the start of administration
of esaxerenone. |
Key secondary outcomes | 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. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | administration of esaxerenone | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (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 |
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Key exclusion criteria | (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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Division of Cardiovascular Medicine, Department of Internal Medicine | ||||||
Zip code | 650-0017 | ||||||
Address | 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo | ||||||
TEL | 078-382-5846 | ||||||
tanakah@med.kobe-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Division of Cardiovascular Medicine, Department of Internal Medicine | ||||||
Zip code | 650-0017 | ||||||
Address | 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo | ||||||
TEL | 078-382-5846 | ||||||
Homepage URL | |||||||
tanakah@med.kobe-u.ac.jp |
Sponsor | |
Institute | Kobe University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kobe University Hospital Clinical & Translational Reserch Center |
Address | 7-5-2, Kusunoki-cho, Chuo-ku, Kobe |
Tel | 078-382-6669 |
cerb@med.kobe-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042581 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |