UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011553
Receipt number R000012951
Scientific Title Comparison of furosemIde with hypertonic saline to carperitide in the treatment of acute decompensated heart failure
Date of disclosure of the study information 2013/09/01
Last modified on 2016/03/29 18:47:45

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Basic information

Public title

Comparison of furosemIde with hypertonic saline to carperitide in the treatment of acute decompensated heart failure

Acronym

CONFIRM ADHF

Scientific Title

Comparison of furosemIde with hypertonic saline to carperitide in the treatment of acute decompensated heart failure

Scientific Title:Acronym

CONFIRM ADHF

Region

Japan


Condition

Condition

acute decompensated heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine safety and effectiveness of continuous infusion of hyperteonic saline with low dose furosemide in comparison with continuous infusion of carperitide with low dose furosemide in the treatment of acute decompensated heart failure.
To examine hyperteonic saline with low dose furosemide has the epual or surpassing diuretic effect to carperitide with low dose furosemide.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

weight reduction from the start of the study to 72 hours after the start

Key secondary outcomes

1. Improvement in edema at 72 hours after start of study.
2. Dyspnea at 6, 24 and 72 hours after the satrt of the study.
3. Urinary volume for 72 hours.
4. Change in renal function.
5. Earlier termination of continuous infusion therapy due to clinical improvement.
6. Need of additional dose of furosemide, inotrope, PDE III inhibitor, CRRT, assisted circulation devices, NPPV and intubation.
7. Occurrence of life-threatening arrhythmia
8. Hospitalization due to worsening heart failure and/or mortality by 30 days and 180 days


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

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hypertonic saline with low dose furosemide group: continuous infusion of 1.6-1.8% salin with 8% furosemide at the sppeed of 20.3 ml/h for 72 hours.

Interventions/Control_2

Carperitide with low dose furosemide group: continuous infusion of hypotonic solution (e.g. 5% glucose solution) with 8% furosemide at the sppeed of 20.3 ml/h and carperitide 0.025 microg/kg/min for 72 hours.

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

1. age 20 and over
2. can obtain written informed concent
3. Systolic BP: 100 mmHg and more
4. eGFR: 15 ml/min/1.73 m2 and more

Key exclusion criteria

1. Diabetes with poor control (HbA1C > 9%).
2. Critical liver dysfunction.
3. Acute coronary syndrome.
4. Acute life-threating disease.
5. HOCM.
6. Critical lung disease.
7. Pulmonary hypertension not due to heart failure.
8. Has experienced myocardial infarction, cerebral infarction, cerebral hemorahge, PCI, and open heart surgery within 3 months.
9. Needs IABP, PCPS, and CRRT.
10. Needs intibation for respiratory management.
11. Hypernatremia (148mEq/l and more)
12. can not obtein body weight
13. Critical cerebrovascular disease.
14. Has already administered inotrope, PDE III, and carperitide.
15. Considered inappropriate for the entry of the study by physician.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masuyama, Tohru

Organization

Hyogo College of Medicine

Division name

Division of Cardiovasucular Medicine

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo

TEL

0798-45-5-6553

Email

masuyama@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirotani, Shinichi

Organization

Hyogo College of Medicine

Division name

Division of Cardiovasucular Medicine

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo

TEL

0798-45-5-6553

Homepage URL


Email

hirotani@hyo-med.ac.jp


Sponsor or person

Institute

CONFIRM ADHF investigation commettiee

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

秋田大学大学医学部附属病院(秋田県)
獨協医科大学医学部附属病院(栃木県)
自治医科大学医学部附属病院(栃木県)
順天堂大学医学部附属病院順天堂医院(東京都)
福島県立医科大学医学部附属病院(福島県)   
鳥取大学医学部附属病院(鳥取県)
関西労災病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 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

Preinitiation

Date of protocol fixation

2013 Year 06 Month 05 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2017 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

2013 Year 08 Month 22 Day

Last modified on

2016 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012951


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name