UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kimura Takeshi

Organization

Kyoto University Hospital

Division name

Cardiovascular internal medicine

Zip code

Address

54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto

TEL

075-751-4254

Email

Name of contact person

1st name
Middle name
Last name	Imai Masao

Organization

Kyoto University Hospital

Division name

Cardiovascular internal medicine

Zip code

Address

54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto

TEL

075-751-4255

Homepage URL

Email

m_imai@kuhp.kyoto-u.ac.jp

Institute

Kyoto University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

10

Month

31

Day

Date of IRB

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

Other related information

Registered date

2012

Year

10

Month

18

Day

Last modified on

2016

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010504