UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039340
Receipt number R000044868
Scientific Title Efficacy and safety of combination therapy with vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure: A randomized controled trial
Date of disclosure of the study information 2020/01/31
Last modified on 2020/05/07 13:07:00

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Basic information

Public title

Efficacy and safety of combination therapy with tolvaptan and dapagliflozin in patients with acute decompensated heart failure: A randomized controled trial

Acronym

Combination therapy of tolvaptan and dapagliflozin in patients with acute decompensated heart failure

Scientific Title

Efficacy and safety of combination therapy with vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure: A randomized controled trial

Scientific Title:Acronym

Combination therapy of vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure

Region

Japan


Condition

Condition

Acute decompensated heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of combination therapy with tolvaptan and dapagliflozin in acute decompensated heart failure

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of 72 hours total urine output between tolvaptan alone therapy vs. combination therapy with tolvaptan and dapagliflozin

Key secondary outcomes

Akute kidney injury during hospitalization
Dose of furosemide at discharge


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tolvaptan alone therapy

Interventions/Control_2

Combination therapy with tolvaptan and dapagliflozin

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

At admission by Acute decompansated heart failure
Patients with diabetes mellitus
Patients without tolvaptan and SGLT2 inhibitor administration
Patients with preserved renal function (eGFR > 30)

Key exclusion criteria

Patients with acute coronary syndrome
Patients with out-of-hospital cardiac arrest
No tolerability of tolvaptan or dapagliflozin
Rejected study enrollment

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Koichiro
Middle name
Last name Matsumura

Organization

Kansai Medical University Medical Center

Division name

Department of Cardiology

Zip code

570-8507

Address

10-15, Fumizono-cho, Moriguchi

TEL

81669921001

Email

kmatsumura1980@yahoo.co.jp


Public contact

Name of contact person

1st name Shinobu
Middle name
Last name Bando

Organization

Kansai Medical University Medical Center

Division name

Department of Cardiology

Zip code

5708507

Address

10-15, Fumizono-cho, Moriguchi

TEL

0669921001

Homepage URL


Email

bandoshi@takii.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JP


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kansai Medical University Medical Center

Address

10-15, Fumizono-cho, Moriguchi

Tel

0669921001

Email

bandoshi@takii.kmu.ac.jp


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

2020 Year 01 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

Open public recruiting

Date of protocol fixation

2020 Year 01 Month 31 Day

Date of IRB

2020 Year 01 Month 31 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 31 Day

Last modified on

2020 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044868


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name