UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047646 |
|---|---|
| Receipt number | R000054329 |
| Scientific Title | Effect of tolvaptan prodrug in patients with acute heart failure who continue oral tolvaptan therapy |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2024/03/15 12:16:53 |
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Basic information
Public title
Effect of tolvaptan prodrug in patients with acute heart failure who continue oral tolvaptan therapy
Acronym
EPIPHANY study
Scientific Title
Effect of tolvaptan prodrug in patients with acute heart failure who continue oral tolvaptan therapy
Scientific Title:Acronym
EPIPHANY study
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of tolvaptan prodrug in patients with acute heart failure who continue oral tolvaptan therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is the proportion of patients with at least moderate improvement in dyspnea by 7-point Likert scale at 6, 24 and 72 h after the randomization, without death or need for rescue therapy, and the improvement in the objective signs of congestion including jugular vein distension and leg edema.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous prodrug of tolvaptan 8 mg/ day, 3 days.
Interventions/Control_2
Oral tolvaptan 7.5 mg/ day, 3 days.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women aged 20 years or older admitted to Izumi City General Hospital with congestive heart failure and volume overload despite treatment with diuretics are included in this study. Only patients who received at least one month oral tolvaptan therapy before the hospitalization are enrolled. Also, patients have to be able to take oral tablets and water. Written informed consent prior to study participation were required.
Key exclusion criteria
Patients are excluded if they have a ventricular assist device, medical conditions that could be adversely affected by aquaretic treatment (e.g., hypovolemia, hypertrophic cardiomyopathy, valvular disease with significant valvular stenosis, hepatic encephalopathy or sepsis), difficulty in achieving adequate fluid intake, myocardial infarction within 30 days prior to screening, ventricular tachycardia or fibrillation within 30 days prior to screening, open heart surgery within 30 days prior to screening, poorly controlled diabetes, anuria, or dysuria with urinary tract obstruction, calculus, or tumor. Additional exclusion criteria are history of cerebrovascular disease (excluding asymptomatic cerebral infarction) within 6 months of screening; systolic blood pressure <90 mm Hg; serum/plasma creatinine >3 mg/ dL, serum/plasma sodium <125 mEq/ L or >147 mEq/ L, or serum/plasma potassium >5.5 mEq/ L; lactation or pregnancy; and any other reason which, in the opinion of the investigators, could endanger the patients or confound study analyses.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Kawase |
Organization
Izumi City General Hospital
Division name
Department of cardiology
Zip code
594-0073
Address
4-5-1, Wake-cho, Izumi
TEL
+81-725-41-1331
y-kawase@js4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Matsumoto |
Organization
Izumi City General Hospital
Division name
Department of cardiology
Zip code
594-0073
Address
4-5-1, Wake-cho, Izumi
TEL
+81-725-41-1331
Homepage URL
matsumoto1110@hotmail.co.jp
Sponsor or person
Institute
Izumi City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Izumi City General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for clinical research, Izumi City General Hospital
Address
4-5-1, Wake-cho, Izumi
Tel
+81-725-41-1331
izumi-chiken@tokushukai.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
和泉市立総合医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | Day |
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
Terminated
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054329
