UMIN-CTR Clinical Trial

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

acute decompensated heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

CONFIRM ADHF investigation commettiee

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

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）

Date of disclosure of the study information

2013

Year

09

Month

01

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

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 related 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