UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short term clinical efficacy and safety of Tolvaptan additional treatment compared with escalation treatment of conventional diuretics in HF patients with volume overload despite treatments with the conventional diuretics
Title of the study (Brief title)	Short term clinical efficacy and safety of Tolvaptan additional treatment compared with dose up conventional diuretics treatment in HF patients with volume overload despite the treatment with the conventional diuretics
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the clinical efficacy and safety of additional tolvaptan treatment by comparing with dose up conventional diuretics treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Body weight change from baseline to day7 and day12 Body weight change from day12 to day14
Key secondary outcomes	Average urine volume from day1 to day7 Congestive symptoms Serum electrolyte concentration Serum creatinine concentration Neurohumoral factors

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	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administered group of loop diuretics furosemide 40mg oral or equivalent
Interventions/Control_2	Administered group of Torvaptan
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who were diagnosed of heart failure. Patients with either congestive symptoms of dyspnea, pulmonary, congestion, pulmonary rale, third heart sound, juglar venous distention, lower limb edema. Patients who received loop diuretics at a daily dosage equivalent to 40 mg or more of furosemide. Male or female patients between the ages of 20 and 85, inclusive (at time of informed consent) Patients capable of giving informed consent to participate in the study of their own free will.
Key exclusion criteria	Patients with a history of hypersensitivity for an ingredient of tolvaptan or an analogue (Mozavaptan) Patients with anuria Patients who cannot feel thirst or are difficult to intake the fluid. Patients with hypernatremia. Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant. Patients who are diagnosed following diseases A) Serious coronary artery disease, cerebrovascular disease B) Hyperkalemia C) Serious Renal failure D) Diabetes mellitus with poorly controlled blood glucose E) Serious hepatic disorder F) Urinary excretion disorder in order to the stenosis of the urinary tract G) Valvular disease that in order to valvular stenosis is severe H) Malignant tumor Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
Target sample size	40

Research contact person
Name of lead principal investigator	Kimura Takeshi
Organization	Kyoto University Hospital
Division name	Cardiovascular internal medicine
Address	54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL	075-751-4254
Email

Public contact
Name of contact person	Imai Masao
Organization	Kyoto University Hospital
Division name	Cardiovascular internal medicine
Address	54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL	075-751-4255
Homepage URL
Email	m_imai@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
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	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 31 Day
Anticipated trial start date	2012 Year 10 Month 31 Day
Last follow-up date
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	2012 Year 10 Month 18 Day
Last modified on	2016 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010504