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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name