UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010872
Receipt number R000012555
Scientific Title Effectiveness and safety of continuous administration of tolvaptan in the treatment of refractory congestive heart failure in a multicenter cohort study
Date of disclosure of the study information 2013/06/12
Last modified on 2013/06/04 20:06:58

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Basic information

Public title

Effectiveness and safety of continuous administration of tolvaptan in the treatment of refractory congestive heart failure in a multicenter cohort study

Acronym

Continuous administration of tolvaptan in the treatment of refractory congestive heart failure

Scientific Title

Effectiveness and safety of continuous administration of tolvaptan in the treatment of refractory congestive heart failure in a multicenter cohort study

Scientific Title:Acronym

Continuous administration of tolvaptan in the treatment of refractory congestive heart failure

Region

Japan


Condition

Condition

refractory congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effectiveness and saty of long term administration of tolvaptan in the patients who were prescribed tolvaptan for reduction of excessive body fluid in hospital and were prescribed tolvaptan as the medicarion at discharge

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Functional heart failure status

Key secondary outcomes

1) change in body weight
2) change in congestion (edema, rales)
3) Blood test (CBC, serum Na, serum K, Uric acid, BUN, Cre)
4) serum osmolality
5) plasma BNP concentration
6) urinary osmolality
7) change in UCG findings
8) change in ECG findings


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with heart failure
They receive tolvaptan when they dischage.
They take loop diuretics, thiazide, and/or aldosterone antagonist

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tohru Masuyama

Organization

Hyogo College of Medicine

Division name

Cardiovascular Medicine

Zip code


Address

1-1 Mukogawa Nishinomiya

TEL

81-798-45-6553

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Hirotani

Organization

Hyogo College of Medicine

Division name

Cardiovascular Medicine

Zip code


Address

1-1 Mukogawa Nishinomiya

TEL

81-798-45-6553

Homepage URL


Email

hirotani@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine, Division of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine, Division of Cardiovascular Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

兵庫医科大学(兵庫県)、関西労災病院 循環器内科(兵庫県)、おおくまセントラル病院(兵庫県)、兵庫県立尼崎病院(兵庫県)、川崎病院(兵庫県)、明和病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 12 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

Preinitiation

Date of protocol fixation

2013 Year 04 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cardiac performance status


Management information

Registered date

2013 Year 06 Month 04 Day

Last modified on

2013 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name