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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012439
Receipt No. R000013411
Official scientific title of the study Acute Effects of Tolvaptan on Acute Exacerbation of Chronic Heart Failure
Date of disclosure of the study information 2013/11/29
Last modified on 2014/11/30

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Basic information
Official scientific title of the study Acute Effects of Tolvaptan on Acute Exacerbation of Chronic Heart Failure
Title of the study (Brief title) ACT-HF
Region
Japan

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

Objectives
Narrative objectives1 The objectives of this study is to evaluate the efficacy of oral tolvaptan administration to compare with standard therapy with carperitide and furosemide injection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Average urinary volume in a day and body weight change, at fifth or the last day of the treatment
Key secondary outcomes 1) NT-proBNP; before and fifth or the last day of the treatment
2) serum Na, K, creatinie; before and fifth or the last day of the treatment
3) IVC diameter by echocardiography; before and fifth or the last day of the treatment
4) urinary osmorarity; before and fifth or the last day of the treatment
5) oxidative stress marker change; serum and urine
6) event frequency during 90 days after hospital discharge
7) cost of heart failure treatment during hospital admission; cost of treatment or admission fee

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

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 not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 treatment with oral topvaptan
Interventions/Control_2 treatment with carperitide and fulosemide injection
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) NYHA class II or III heart failure patient with volume overload
2) patient who can take medicine orally
3) patient who's systolic blood pressure is 90 mmHg or more at hospital admission
4) patient who is at least 20 years old when he or she agreed to this study
5) patient who agreed within 24 hours after hospital admission
Key exclusion criteria 1) heart failure patient by coronary artery disease
2) patient who has allergic past history to tolvaptan or relative chemicals
3) patient of no urine production
4) patient who do not feel thirsty or have difficulty to take water orally
5) patient who is hypernatremia
6) patient who is pregnant or might be pregnant
7) patient who is very low blood pressure or cardiogenic shock state
8) patient who suffers right ventricular myocardial
infarction
9) patient who have dehydration
10) patient who is assessed to be inappropriate for the study by study investigators
Target sample size 30

Research contact person
Name of lead principal investigator Koji Maemura
Organization Nagasaki University
Division name Cardiovasucular Medicine
Address 1-7-1 Sakamoto Nagasaki, Nagasaki, JAPAN
TEL +81-95-819-7288
Email maemura@nagasaki-u.ac.jp

Public contact
Name of contact person Yuji Koide
Organization Nagasaki University Hosital
Division name Cardiovascular Medicien
Address 1-7-1 Sakamoto Nagasaki, Nagasaki, JAPAN
TEL +81-95-819-7288
Homepage URL
Email ykoide1@nagasaki-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 29 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 07 Month 24 Day
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 11 Month 29 Day
Last modified on
2014 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013411


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