Japanese Multicenter Evaluation of LOng- versus short-acting Diuretics In Congestive heart failure

UMIN ID: UMIN000000528

Registered date:24/11/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: congestive heart failure
• Date of first enrollment: 2006/06/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: A composite of cardiovascular death and unplanned admission to hospital for congestive heart failure.
• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: The J-MELODIC Program Committee
• Source(s) of Monetary Support: The ministry of health, labor and welfare, Japan
• Secondary ID(s): NCT00355667