UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014312
Receipt number R000016339
Scientific Title Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease.
Date of disclosure of the study information 2014/07/01
Last modified on 2018/08/29 17:21:39

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Basic information

Public title

Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease.

Acronym

TOLVAPTAN study

Scientific Title

Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease.

Scientific Title:Acronym

TOLVAPTAN study

Region

Japan


Condition

Condition

Chronic congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effects of tolvaptan for chronic heart failure with chronic kidney disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement effect of the heart failure

Key secondary outcomes

BNP, renin activity, aldosteron, catecholamine, CRE, cystatin C, urine L-FABP


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

Tolvaptan

Interventions/Control_2

Furosemide

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients of congestive heart failure hospitalized with the chronic kidney disease that presented body fluid retention even if taken more than furosemide 20mg/day.

Key exclusion criteria

Patients who had acute myocardial infarction within 30 days .
Patients of active myocarditis or the amyloid cardiomyopathy.
Patients who are supported by circulation device.
Patients who had decrease in circulation blood volume.
Patients with hypertrophic cardiomyopathy (except the expansion aspect).
Patients with severe valvular disease.
Patients with hepatogenic comatose.
Patients with insufficient treatment on diabetes mellitus.
Patients whose blood pressure is less than 90mmHg.
Patients that following electrolytes abnormality is accepted.
Serum Na>147mEq/L, serum K>5.5mEq/L
Patients who cannot take oral formulation.
Patients with a pregnant woman, a nursing girl, pregnant possibility or the intention to become pregnant.
Patients that are recognized as inappropriate for this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Minatoguchi

Organization

Gifu University Graduate School of Medicine

Division name

Department of Cardiology

Zip code


Address

1-1 Yanagido, Gifu

TEL

058-230-6523

Email

minatos@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinya Minatoguchi

Organization

Gifu University Graduate School of Medicine

Division name

Department of Cardiology

Zip code


Address

1-1 Yanagido, Gifu

TEL

058-230-6523

Homepage URL


Email

minatos@gifu-u.ac.jp


Sponsor or person

Institute

Department of Cardiology, Gifu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology, Gifu University Graduate School of Medicine

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


Address


Tel


Email



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

2014 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

Open public recruiting

Date of protocol fixation

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 06 Month 19 Day

Last modified on

2018 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016339


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name