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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021994
Receipt No. R000025346
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
Date of disclosure of the study information 2016/04/20
Last modified on 2018/04/23

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Basic information
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
Condition Patients with moderate congestive heart failure
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Sanwa Kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 20 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 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
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.

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2018 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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