congestive heart failure
Conditions
Interventions
tolvaptan0.125mg/kg*2/day
Sponsors
Kanagawa Children's Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. heart failure patients who are already administered diuretics due to congenital heart disease 2. patients who can keep using fixed-dose existing diuretics for 12 hours from the start of tolvaptan administration. 3. congestive heart failure patients with volume overload who have tachycardia, polypnea(>=40/min), central venous pressure(7-8mmHg) or pulmonary congestion (chest x-ray). 4. patients who are under 10 years old ( at the time of informed consent) 5. inpatient
Exclusion criteria
Exclusion criteria: 1. patients who have circulation assist 2. patients who have diseases, complications or symptoms as follows: *possibly hypovolemic *hypertrophic cardiomyopathy *hepatic coma *severe diabetes *anuria *urinary stenosis, calculus or impairment of urinary excretion due to tumor 3. patients who have a history as follows: *cerebrovascular disease (asymptomatic is excluded) *patients who have a history of allergy against benzazepine 4. patients whose laboratory test are as follows(at least 1 item) *total bilirubin >3.0mg/dL *serum creatinine >3.0mg/dL *serum Na >147mEq/L *serum K >5.5mEq/L 5. patients who are judged to be inappropriate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight, CTR, urinary output and safety | — |
Countries
Japan
Contacts
Public ContactHideaki Ueda
Kanagawa Children's Medical Center Cardiology
Outcome results
None listed