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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012317
Receipt No. R000014403
Scientific Title Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Date of disclosure of the study information 2013/11/16
Last modified on 2013/11/16

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Basic information
Public title Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Acronym Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Scientific Title Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Scientific Title:Acronym Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Region
Japan

Condition
Condition Acute decompensated heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of Tolvaptan and Carperitide in acute decompensated heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Length of hospitalization, Cost of hospitalization, One-year prognosis, Time to MACE, readmission for worsening of heart failure and death from any cause)
Number of hospitalizations
Key secondary outcomes Changes in renal function, serum sodium and plasma BNP level
Improvement of the signs of congestion assessed by physical examination, chest X-ray and echocardiography

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 switch from Carperitide to Tolvaptan within 48 hours after admission
Interventions/Control_2 continue Carperitide
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 Acute decompensated heart failure patients initially treated with low-dose Carperitide who meet all of following criteria
1) Heart failure patients diagnosed by Framingham criteria
2) Patients with refractory fluid retention 48hrs after admission in spite of loop-diuretic therapy(equivalent to >20mg frosemide dose)
3) In-hospital patients at entry
4) 20 years of age and older patients at entry
5) Patients with written informed consent
6) Paients irrespective of sex
Key exclusion criteria 1)Patients who already have tolvaptan at entry
2) Hypernatremia(serum Na>145mEq/L)
3) Insensitivity to thurst or difficulty in water intake
4) Anuria
5) Pregnant or possibly pregnant
6) History of hypersensitivity to Tolvaptan
7) Any conditions inappropriate to this trial deemed by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Watarai
Organization Anjo Kosei Hospital
Division name Department of Cardiology
Zip code
Address 28 Higashihirokute, Anjo-cho, Anjo city, Aichi Pref. JAPAN
TEL 0566-75-2111
Email watarai@kosei.anjo.aichi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Miura
Organization Anjo Kosei Hospital
Division name Department of Cardiology
Zip code
Address 28 Higashihirokute, Anjo-cho, Anjo city, Aichi Pref. JAPAN
TEL 0566-75-2111
Homepage URL
Email amiura@kosei.anjo.aichi.jp

Sponsor
Institute Anjo Kosei Hospital
Institute
Department

Funding Source
Organization None
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 安城更生病院(愛知県)
Anjo Kosei Hospital(Aichi Pref.)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 12 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 16 Day
Last modified on
2013 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014403

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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