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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013807
Receipt No. R000015336
Scientific Title Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure
Date of disclosure of the study information 2014/04/25
Last modified on 2017/07/23

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Basic information
Public title Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure
Acronym Clinical Effect of Long-term Tolvaptan Administration
Scientific Title Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure
Scientific Title:Acronym Clinical Effect of Long-term Tolvaptan Administration
Region
Japan

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

Objectives
Narrative objectives1 To examine the clinical effect of long-term Tolvaptan administration in patients with heart failure with fluid retention. Especially, to examine the effects of neurohormonal factors and renal function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes in neurohormonal factors (catecholamine, renin activity, aldosterone, copeptin)
Key secondary outcomes The finding of fluid retention, the changes in serum sodium, BUN, Cr, urinary L-FABP, dosage of diuretics, blood pressure, heart rate and 6-month prognosis (readmission and death)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Assigned following 2 groups, when heart failure treatment is hemodynamically stable.
TLV group: Add on tolvaptan (1.875mg/day to 15mg/day) with conventional diuretics for 6 months.
Interventions/Control_2 Conventinal diuretics group: Treat with conventional diuretics except tolvaptan for 6 months.
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 Heart failure in-hospital patients with fluid retention
Required continuous diuretics treatment
Key exclusion criteria Patients with a history of hypersensitivity for tolvaptan or an analogue.
Anuresis or hypernatremia.
Patients who have difficulty with fluid intake or can not feel dipsesis.
Pregnant woman or possibility of the pregnancy.
Patients whom tolvaptan is already given at registration.
Patients whom study responsibility physician judged inappropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Iida
Organization Nihon University Surugadai Hospital
Division name Department of Cardiology
Zip code
Address 1-8-13 Kanda-Surugadai, Chiyoda, Tokyo
TEL 03-3293-1711
Email kiida2830@jcom.home.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Iida
Organization Nihon University Surugadai Hospital
Division name Department of Cardiology
Zip code
Address 1-8-13 Kanda-Surugadai, Chiyoda, Tokyo
TEL 03-3293-1711
Homepage URL
Email kiida2830@jcom.home.ne.jp

Sponsor
Institute Nihon University Surugadai Hospital
Institute
Department

Funding Source
Organization none
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 駿河台日本大学病院(東京都)、日本大学板橋病院(東京都)、聖路加国際病院(東京都)、三井記念病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 25 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
2014 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 03 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 04 Month 25 Day
Last modified on
2017 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015336

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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