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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014134
Receipt No. R000015841
Scientific Title The effect of tolvaptan on renal function during intensive treatment in patients with congestive heart failure
Date of disclosure of the study information 2014/05/31
Last modified on 2014/11/04

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Basic information
Public title The effect of tolvaptan on renal function during intensive treatment in patients with congestive heart failure
Acronym Renoprotective effect of tolvaptan in acute phase of patients with congestive heart failure
Scientific Title The effect of tolvaptan on renal function during intensive treatment in patients with congestive heart failure
Scientific Title:Acronym Renoprotective effect of tolvaptan in acute phase of patients with congestive heart failure
Region
Japan

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

Objectives
Narrative objectives1 To compare the effect on renal function, hemodynamics and neurohumoral factors in acute phase of HF patients between tolvaptan and furosemide.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes renal function
Key secondary outcomes 1. daily urine volume, fluid balance
2. plasma renin activity, plasma aldosterone concentration, catecholamines, BNP
3. systemic blood pressure
4. electrolytes
5. cardio-thoracic ratio
6. durations of NIPPV use, CCU and total hospitalization
7. in-hospital and long-term mortality

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 (Standard treatment group)
Daily 40 mg of intravenous furosemide (20 mg x 2), in addition to intravenous 0.025 gamma of carperitide and 200 mg of canrenoate potassium for 5 days. Renal functions and neurohumoral factors were evaluated on day 6 after the admission.
Interventions/Control_2 (Tolvaptan treatment group)
Daily 7.5 mg of oral Tolvaptan administration (7.5 mg x 1), in addition to intravenous 0.025 gamma of carperitide and 200 mg of canrenoate potassium for 5 days. Renal functions and neurohumoral factors were evaluated on day 6 after the admission.
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
30 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient urgently hospitalized due to acute heart failure syndrome, or worsened chronic heart failure, with informed consent.
Key exclusion criteria (i) Patient with malignant neoplasm who is expected that life expectancy is within 6 months
(ii) Maintenance dialysis patient
(iii) Patient with shock or pre shock vital signs on admission
(iv) Patient younger than 30 years old
(v) Inadequate patient judged by principal investigator
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Email juken1123@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Homepage URL
Email juken1123@hotmail.co.jp

Sponsor
Institute Nishiarai Heart Center Hospital
Institute
Department

Funding Source
Organization Nishiarai Heart Center Hospital
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 西新井ハートセンター病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 31 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
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 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 05 Month 31 Day
Last modified on
2014 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015841

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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