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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009810
Receipt No. R000011499
Scientific Title Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Date of disclosure of the study information 2013/01/19
Last modified on 2013/01/19

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Basic information
Public title Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Acronym Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Scientific Title Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Scientific Title:Acronym Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Region
Japan

Condition
Condition congestive heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of tolvaptan for improvements in renal function and time to re-hopitalization in congestive heart failure patients with volume overload.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of change of serum creatinine
Key secondary outcomes body weight, daily urine volume, dyspnea, congestive findings(leg edema, jugular vein dilatation, pulmonary congestion ), serum sodium, serum potassium, cystitis C, time to re-hospitalization.

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conventional therapy only
Interventions/Control_2 Conventional therapy with 14 days administration of tolvaptan 7.5mg/day.
Interventions/Control_3 Conventional therapy with 7 days administration of tolvaptan 15mg/day.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Congestive heart failure patients to administrating loop diuretics with volume overload in hospital.
Key exclusion criteria 1) Patients who a history of hypersensitivity to tolvaptan
2) Patients with severe hypotention or cardioganic shock
3) Patients with cardiac assist device
4) Patients with dehydration
5) Patients with systolic blood pressure < 90mmHg
6) Patients with serum Na > 147 mEq/L or serum K > 5.5 mEq/L or T- bilirubin > 3.0 mg/dL
7)Patients considered not eligible for the study by the attending doctor due to other reasons
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Take
Organization Saiseikai Noe hospital
Division name Department of cardiology
Zip code
Address 1-3-25, furuichi, joto-ku, osaka city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro kato
Organization Saiseikai Noe hospital
Division name Department of cardiology
Zip code
Address 1-3-25, furuichi, joto-ku, osaka city
TEL 0669320401
Homepage URL
Email

Sponsor
Institute Saiseikai Noe hospital
Institute
Department

Funding Source
Organization Department of cardiology
Saiseikai Noe 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
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
2013 Year 01 Month 19 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 19 Day
Last modified on
2013 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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