UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007943
Receipt number R000009357
Scientific Title TOLvaptan Effects on RenAl FuNCtion in Heart FailurE
Date of disclosure of the study information 2012/05/14
Last modified on 2014/09/09 21:45:08

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Basic information

Public title

TOLvaptan Effects on RenAl FuNCtion
in Heart FailurE

Acronym

TOLERANCE

Scientific Title

TOLvaptan Effects on RenAl FuNCtion
in Heart FailurE

Scientific Title:Acronym

TOLERANCE

Region

Japan


Condition

Condition

congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evalute the efficacy and safety of tolvaptan in treating heart failure patients with volume overload despite the use of loop diuretics (Furosemide 20-80mg/day).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in eGFR, Changes in serum sodium

Key secondary outcomes

Worsening Renal Function(WRF), leg edema, dyspnea, death due to heart failure and fatal arrhythmia(VT/VF), PRA, PAC, BNP, body weight, echocardiogram


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

YES

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tolvaptan group: Add 7.5mg/day administration. If the effect is insufficient, to enable increased up to 15mg/day

Interventions/Control_2

Furosemide group: Add furosemide administration

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

18 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Heart failure patients with volume overload despite the use of loop diuretics (Furosemide 20-80mg/day).

Key exclusion criteria

1) Patients with decompensated HF in acute period
2) Patients with cardiac assist device
3) Patients with dehydration
4) Patients with severe hypotention or cardioganic shock
5) Patients with impaired consciousness
6) Patients who cannot feel thirst and are difficult to intake of fluid
7) Patient who is evaluated to be undesirable rapid decrease in circulating plasma volume
8) Patients who a history of hypersensitivity to tolvaptan
9) Patients with anuria, dialysis patient
10) Patients with severe aortic stenosis, mitral stenosis
11) Scheduled patients underwent coronary angioplasty within the study period, and patients with acute coronary syndrome
12) Hypertrophic obstructive cardiomyopathy
13) Patients with hypernatremia(serum Na+ >145 mEq/L)
14) Patients with hyperpotassemia(serum K+ >5.5 mEq/L)
15) Patient is willing to pregnant or potentially pregnant women, nursing mothers, pregnant
16) Patients with cancer
17) Patients considered not eligible for the study by the attending doctor due to other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Ogawa

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Cardiovascular medicine

Zip code


Address

Honjyo 1-1-1, Kumamoto

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Megumi Yamamuro

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Cardiovascular medicine

Zip code


Address

Honjyo 1-1-1, Kumamoto

TEL

096-373-5175

Homepage URL


Email

yamamuro@kumamoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medical Sciences, Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2012 Year 05 Month 14 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

Completed

Date of protocol fixation

2011 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 05 Month 14 Day

Last modified on

2014 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009357


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name