chronic heart failure
Conditions
Interventions
Intervention group: Patients in whom furosemide of 20 mg was partly replaced by tolvaptan of 3.75 or 7.5 mg a day as an alternative in patients with heart failure receiving furosemide more than 40 mg
Sponsors
Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are older than 20 years and have been receiving loop diuretics of the amount equivalent to more than 40 mg a day of furosemide due to chronic heart failure. The patients with in stable condition without changes in both symptoms and therapy of heart failure within one month prior to the enrolment.
Exclusion criteria
Exclusion criteria: 1. Patients who have already received tolvaptan therapy. Patients who are more than 80 years and have difficulty in complain thirst. 2. Patients with renal dysfunction having an estimated glomerular filtration rate 30mL or less /min/1.73m2 and/or requiring hemodialysis. 3. Patients with liver dysfunction which is defined as an increase threefold in aspartate aminotransferase and/or alanine aminotransferase compared to the upper limit of normal range. 4. Patients with percutaneous coronary intervention or open heart surgery within the past 3 months. 5. Patients under the pacing therapy using implantable cardiac pacemaker, cardiac resynchronization therapy device, or implantable cardiac defibrillator. 6. Patients with type 1 diabetes mellitus. 7. Patients with endocrine diseases such as thyroid dysfunction, or adrenal dysfunction which may have an effect on balance of body fluid. 8. Patients with any serious non-cardiovascular disease including malignancy, which have expected 6 months or less to live. 9. Patients without agreement on enrolment of this trial through written texts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in BNP levels from the enrolment in this trial to 2 months later. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in renal functional parameters: creatinine clearance, urinary microalbumin excretion, and urinary L-FABP excretion, from the enrolment in this trial to 2 months later. 2) Adverse events which are defined as all cause death, worsening of heart failure requiring an increase in an amount of loop diuretics, and ventricular arrhythmia which need cardioversion or defibrillation, during the period from the enrolment in this trial to 2 months later. 3) Adverse events which are defined as cardiovascular death and/or hospitalization for heart failure during 6 months after 2 months intervention period. | — |
Countries
Japan
Contacts
Public ContactShuichi Kitada
Nagoya City University, Japan Department of Cardio-Renal Medicine and Hypertension
Outcome results
None listed