UMIN-CTR Clinical Trial

Public title

patientes with CONgestive heart failure benefit for long-TErm treatment effects with New Treatment using azosemide compared with furosemide
derived from Existing retrospective study Data

Acronym

patientes with CONgestive heart failure benefit for long-TErm treatment effects with New Treatment using azosemide compared with furosemide
derived from Existing retrospective study Data (CONTENTED study)

Scientific Title

patientes with CONgestive heart failure benefit for long-TErm treatment effects with New Treatment using azosemide compared with furosemide
derived from Existing retrospective study Data

Scientific Title:Acronym

patientes with CONgestive heart failure benefit for long-TErm treatment effects with New Treatment using azosemide compared with furosemide
derived from Existing retrospective study Data (CONTENTED study)

Region

Japan

Condition

Patients with moderate congestive heart failure

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of the prognosis in the long-acting loop diuretics by comparing to the treatment results of short-acting loop diuretics in patients with moderate congestive heart failure

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of "Cardiovascular death + Hospitalization for heart failure"

Key secondary outcomes

Secondary outcomes are chosen based on J-MELODIC:
* Incidences of "cardiovascular death", "hospitalization for heart failure" and "death caused by other reasons"
* Change in CTR
* Change in BNP
* Change in LVEF (calculated based on the modified Simpson's rule)
* Change in severity of heart failure (NYHA classification)
* Change in other measured values

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

Patients who meet all of the following criteria are included in this study.
1. First time ever to be admitted to this hospital for heart failure from the beginning of April 2008 to the end of July 2015

2. At age of 20 or older and started an oral agent of azosemide or furosemide during her/his stay in this hospital; however, anyone who started either oral agent before coming to this hospital did not change their dosage throughout the observation period can be qualified to be in this study.

3. Oral agent of azosemide or furosemide is continued for a year or longer with mild to moderate congestive heart failure, as well as those with the medication last less than a year and either deceased* or re-admitted* to the hospital. Patients with suspension of oral agents due to the use of furosemide injection during hospitalization can be enrolled.

4. With LVEF below 50%, hospitalization for heart failure is the first time

5. Heart condition categorized as mild to moderate congestive heart failure is stabled

* For those who are deceased, the patient used azosemide or furosemide up to the death is qualified to this study.
For those who are re-admitted, the patient continued to use azosemide or furosemide up to the re-admission is qualified to this study.

Key exclusion criteria

Patients who fall into any of the following criteria before discharge (from hospital) are excluded. The value "before discharge" means the last value collected before the patient leaves the hospital.
1. Blood glucose is inadequately controlled (hemoglobinA1c is over 9%, or over 200mg/dl at fasting state)

2. Symptomatic hypoglycemia

3. Inadequately controlled blood glucose with systolic blood pressure over 180mmHg

4. Serum Cr is over 2.5 mg/dl

5. Severe liver impairment, or any other acute and life-threating impairment

6. Has artificial auxiliary heart implanted

7. Complicated with severe chronic obstructive pulmonary disease or locality lung disease

8. Neither primary pulmonary hypertension nor left ventricular impairment is the cause of current pulmonary hypertension

9. Patients with acute coronary syndrome or cerebrovascular impairment, or underwent PCI or thoracotomy for cardiac surgery within last three months before hospitalization due to heart failure

10. Patients underwent treatment of
cardiac resynchronization therapy, intraaortic balloon pumping, left ventricular assist device, or heart transplant due to heart failure

11. Severe cerebrovascular impairment

12. One type of loop diuretics other than azosemide or furosemide is prescribed

13. Currently using tolvaptan (Patients who temporally used tolvaptan during hospitalization can be enrolled)

14. Anyone who refuses to have their information used in this study

15. Patients need certain amount of azosemide or furosemide that is beyond health insurance coverage

16. Anyone with a condition judged by the physician (investigator) to be inappropriate for this study

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Prof. Teruo Inoue

Organization

Dokkyo Medical University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

Address

880 Kitakobayashi, Mibumachi, Shimotsugagun, Tochigi

TEL

0282-87-2146

Email

inouet@dokkyomed.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroki Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code

Address

NBF Ogawamachi Building 4F, 1-3-1, Kanda, Ogawamachi, Chiyoda-ku, Tokyo 101-0052

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Dokkyo Medical University

Institute

Department

Personal name

Organization

Sanwa Kagaku Kenkyusho Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

2016

Year

04

Month

20

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

Completed

Date of protocol fixation

2016

Year

02

Month

19

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This retrospective study is to compare the prognosis of long-acting loop diuretics (azosemide) to the short-acting loop diuretics (furosemide) using data from patients with congestive heart failure. Among the patients who are admitted to the hospital during April 2008 to the end of July 2015, are included in the study, and the incidence of "Cardiovascular death + Hospitalization for heart failure" is evaluated as the main outcome.

Registered date

2016

Year

04

Month

20

Day

Last modified on

2018

Year

04

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025346