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Trial record 98 of 242 for:    furosemide

Comparison of Long- and Short-acting Diuretics in Congestive Heart Failure (J-MELODIC)

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ClinicalTrials.gov Identifier: NCT00355667
Recruitment Status : Completed
First Posted : July 24, 2006
Last Update Posted : August 18, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Tohru Masuyama, Hyogo College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: furosemide Drug: azosemide Phase 4

Detailed Description:

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.

Comparison: Congestive heart failure patients matched with the following conditions will be recruited: (1) clinical diagnosis of heart failure based on a slight modification of the Framingham criteria within 6 months before the entry, (2) twenty years or older, (3) NYHA II or III, (4) loop diuretic(s) is (are) administered currently, (5) no change in baseline therapy and symptoms of heart failure within a month. After screening for eligibility and obtaining written informed consent, patients will be randomized to either azosemide or furosemide treatment in a 1:1 ratio. In any arms, patients are treated with standard therapy including digitalis, mineralocorticoid receptor blockers, ACE inhibitors, ARB, beta-blockers, and calcium channel blockers. Patients discontinued taking previous loop diuretic(s) and were directly rolled over to one of the two arms with either azosemide 30-60 mg/day or furosemide 20-40 mg/day, without a placebo run-in period. 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. Thereafter, patients are reviewed every 2 to 8 weeks. The planned minimum follow-up period for each patient is 2 years, and electrocardiography, chest X-ray and blood sample will be conducted at the study entry and every 12 months after the randomization.

The primary outcome is a composite of cardiovascular death and unplanned admission to hospital for congestive heart failure. The secondary outcomes are listed as follows: all cause mortality; worsening of the symptoms [that is defined by either a decrease by (1) 1 Mets in the SAS questionnaire score or an increase by (2) I class in the NYHA functional class for at least 3 months as compared with the baseline]; an increase in brain natriuretic peptide (BNP) by more than 30% of the value at the randomization in patients with BNP less than 200 pg/ml at the randomization; 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Japanese Multicenter Evaluation of Long- Versus Short-acting Diuretics in Congestive Heart Failure
Study Start Date : June 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: A
Patients with chronic heart failure with NYHA II or III are given furosemide.Patients discontinued taking previous loop diuretic(s) and were directly rolled over to the arm with furosemide 20-40 mg/day, without a placebo run-in period. The dose of each diuretic was appropriately adjusted according to symptoms of each patient, and patients were maintained for the rest of the study. Thereafter, patients were reviewed every 2 to 8 weeks. The planned minimum follow-up period for each patient was 2 years, and electrocardiography, chest X-ray and blood sample were conducted at the study entry and every 12 months after the randomization.
Drug: furosemide
Patients with chronic heart failure receive furosemide and other standard treatment/
Other Name: Lasix

Active Comparator: B
Patients with chronic heart failure with NYHA II or III are given azosemide.Patients discontinued taking previous loop diuretic(s) and were directly rolled over to the arm with azosemide 30-60 mg/day without a placebo run-in period. The dose of azosemide was appropriately adjusted according to symptoms of each patient, and patients were maintained for the rest of the study. Thereafter, patients were reviewed every 2 to 8 weeks. The planned minimum follow-up period for each patient was 2 years, and electrocardiography, chest X-ray and blood sample were conducted at the study entry and every 12 months after the randomization.
Drug: azosemide
Patients with chronic heart failure receive azosemide and other standard treatment.
Other Name: Daiart




Primary Outcome Measures :
  1. a composite of cardiovascular death and unplanned admission to hospital for congestive heart failure [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: 2 years ]
  2. worsening of the symptoms (that is defined by either a decrease by <1 Mets in the SAS questionnaire score or an increase by >I class in the NYHA functional class for at least 3 months as compared with the baseline) [ Time Frame: 2 years ]
  3. an increase in brain natriuretic peptide (BNP) by > 30% of the value at the randomization in patients with BNP < 200 pg/ml at the randomization [ Time Frame: 2 years ]
  4. 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) [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of heart failure based on a slight modification of the Framingham criteria as previously described within 6 months before the entry
  • Current status of heart failure is NYHA II or III.
  • Currently, loop diuretic(s) is (are) administered.
  • No change in baseline therapy and symptoms of heart failure within a month

Exclusion Criteria:

  • Current symptomatic hypotension
  • Hypertension that has not been controlled to the satisfaction of the investigator
  • Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy)
  • Acute coronary syndrome
  • Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction
  • Serious cerebrovascular disease
  • Acute myocardial infarction within the last 3 months
  • Patients who require intravenous inotropes
  • Cerebrovascular accident within the last 3 months
  • Percutaneous coronary intervention or open heart surgery within the last 3 months
  • On the waiting list for percutaneous coronary intervention or open heart surgery
  • Serum creatinine > 2.5 mg/dl
  • Serious liver disease
  • Any change in cardiovascular drug therapy within a month prior to randomization
  • History of chronic obstructive pulmonary disease or restrictive lung disease
  • Diabetes mellitus that has not been well controlled (fasting blood glucose>200 mg/dl、HbA1c > 8%)
  • Any life-threatening acute disease
  • Patients with implantable cardiac defibrillator
  • Other diseases likely to cause death or serious disability during the period of the study
  • Patients unable to walk without personal aid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355667


Locations
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Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
Sponsors and Collaborators
Hyogo College of Medicine
Ministry of Health, Labour and Welfare, Japan
Investigators
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Principal Investigator: Tohru Masuyama, MD, PhD Cardiovascular Division, Hyogo College of Medicine

Publications of Results:
Other Publications:
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Responsible Party: Tohru Masuyama, Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine
ClinicalTrials.gov Identifier: NCT00355667     History of Changes
Other Study ID Numbers: H18-Junkanki(seishu)-ippan-046
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Tohru Masuyama, Hyogo College of Medicine:
diuretics
furosemide
azosemide
congestive heart failure
Additional relevant MeSH terms:
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Furosemide
Heart Failure
Heart Diseases
Cardiovascular Diseases
Sulfanilamides
Azosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents