UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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 (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	Prof. Teruo Inoue
Organization	Dokkyo Medical University Hospital
Division name	Department of Cardiovascular Medicine
Address	880 Kitakobayashi, Mibumachi, Shimotsugagun, Tochigi
TEL	0282-87-2146
Email	inouet@dokkyomed.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025346