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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000528
Receipt No. R000000637
Scientific Title Japanese Multicenter Evaluation of LOng- versus short-acting Diuretics In Congestive heart failure
Date of disclosure of the study information 2006/11/24
Last modified on 2011/06/08

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Basic information
Public title Japanese Multicenter Evaluation of LOng- versus short-acting Diuretics In Congestive heart failure



Acronym J-MELODIC
Scientific Title Japanese Multicenter Evaluation of LOng- versus short-acting Diuretics In Congestive heart failure



Scientific Title:Acronym J-MELODIC
Region
Japan

Condition
Condition congestive heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The mortality and morbidity of heart failure are still high despite emerging evidences that have shown beneficial effects of ACE inhibitor, beta-blocker, ARB, and aldosterone receptor antagonist. Diuretics are the most prescribed in heart failure patients in attenuating symptoms due to fluid retention, and diuretics are recommended as essential medicines in patients with heart failure symptoms and/or fluid retention. However, the effects of a long-term administration of diuretics on morbidity and mortality have not been adequately assessed in the prospective clinical study, and the retrospective analysis did not necessarily indicate the diuretic-induced improvement of mortality. McCurley et al demonstrated the adverse effects of furosemide in a tachycardia-induced heart failure model (J Am Coll Cardiol 2004; 44: 1301-1307). Yoshida et al. demonstrated that the administration of furosemide did not improve mortality rate, while the administration of azosemide, a long-acting loop diuretic, improved mortality rate in a hypertensive heart failure model (Cardiovasc Res 2005; 68: 118-127). If the effects on mortality and/or morbidity of heart failure patients are different among classes of diuretics, we should choose a class to provide better prognosis. Thus, we designed a multicenter prospective study, J-Melodic (Japanese Multicenter Evaluation of LOng- versus short-acting Diuretics In Congestive heart failure) to obtain a clinical evidence about the effects of diuretics in heart failure. The purpose of this study is to compare therapeutic effects of furosemide, a short-acting loop diuretic, and azosemide, a long-acting one, in patients with heart failure, and to test our hypothesis that long-acting diuretics are superior to short-acting types in heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes A composite of cardiovascular death and unplanned admission to hospital for congestive heart failure.
Key secondary outcomes 1. All cause mortality
2. Worsening of the symptoms [that is defined by either a decrease by (a) 1 Mets in the SAS questionnaire score or an increase by (b) I class in the NYHA functional class for at least 3 months as compared with the baseline]
3. An increase in brain natriuretic peptide (BNP) by more than 30% of the value at the randomization in patients with BNP more than or equal to 200 pg/ml at the randomization.
4. Unplanned admission to hospital for congestive heart failure, or a need for modification of the treatment for heart failure (changes in oral medicine for at least one month or addition of intravenous drug(s) for at least 4 hours).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After screening for eligibility and obtaining written informed consent, patients will be randomized to 2 groups in a 1:1 ratio. Patients discontinued taking previous loop diuretic(s) and are directly rolled over to one of the two arms. One arm is azosemide group, and patients will take azosemide 30-60 mg/day without a placebo run-in period. Patients are treated with standard therapy including digitalis, mineralocorticoid receptor blockers, ACE inhibitors, ARB, beta-blockers, and calcium channel blockers. The dose of each diuretic will be appropriately adjusted according to symptoms of each patient, and patients will be maintained for the rest of the study. The planned minimum follow-up period for each patient is 2 years, and SAS evaluation, electrocardiography, chest X-ray and blood sample will be conducted at the study entry and every 12 months after the randomization.
Interventions/Control_2 After screening for eligibility and obtaining written informed consent, patients will be randomized to 2 groups in a 1:1 ratio. Patients discontinued taking previous loop diuretic(s) and are directly rolled over to one of the two arms. One arm is furosemide group, and patients will take furosemide 20-40 mg/day without a placebo run-in period. Patients are treated with standard therapy including digitalis, mineralocorticoid receptor blockers, ACE inhibitors, ARB, beta-blockers, and calcium channel blockers. The dose of each diuretic will be appropriately adjusted according to symptoms of each patient, and patients will be maintained for the rest of the study. The planned minimum follow-up period for each patient is 2 years, and SAS evaluation, electrocardiography, chest X-ray and blood sample will be conducted at the study entry and every 12 months after the randomization.
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. Clinical diagnosis of heart failure based on a slight modification of the Framingham criteria within 6 months before the entry
2. NYHA II or III
3. No change in baseline therapy and symptoms of heart failure within a month
4. Loop diuretic(s) is (are) administered currently
5. Written informed consent was obtained.
Key exclusion criteria 1. Diabetes mellitus that has not been well controlled (fasting blood glucose > 200 mg/dl, HbA1c > 9%)
2. Current symptomatic hypotension
3. Hypertension that has not been controlled to the satisfaction of the investigator
4. Serum creatinine > 2.5 mg/dl
5. Serious liver disease
6. Acute coronary syndrome
7. Any life-threatening acute disease (including patients with implantable cardiac defibrillator)
8. Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy)
9. Chronic obstructive pulmonary disease or restrictive lung disease
10. Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction
11. Acute myocardial infarction or cerebrovascular accident within the last 3 months
12. Percutaneous coronary intervention or open heart surgery within the last 3 months
13. Any change in cardiovascular drug therapy within a month prior to randomization
14. Malignancy
15. Surgery for resecting malignant tumor within 5 years
16. Patients unable to walk without personal aid
17. Serious cerebrovascular disease
18. Patients who require intravenous inotropes
19. Pregnancy
20. Patients who were judged not to be suitable for entry by physicians
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo College of Medicine
Division name Cardiovascular Division, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6553
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Tsujino
Organization Hyogo College of Medicine
Division name Cardiovascular Division, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6553
Homepage URL http://j-melodic.com/
Email jmelodic@hyo-med.ac.jp

Sponsor
Institute The J-MELODIC Program Committee
Institute
Department

Funding Source
Organization The ministry of health, labor and welfare, Japan
Organization
Division
Category of Funding Organization
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 YES
Study ID_1 NCT00355667
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 24 Day

Related information
URL releasing protocol http://j-melodic.com/
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
2006 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 11 Month 23 Day
Last modified on
2011 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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