Congestive heart failure
Conditions
Interventions
Tolvaptan 15mg/day
Sponsors
St. Marianna University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)patients who are already administered diuretics at least 3 days prior to tolvaptan's administration (2)patients who can keep using fixed-dose furosemide (40-200mg) (3)congestive heart failure patients who have lower limb edema, pulmonary congestion or jugular venous distention due to volume overload (4)subjects whose eGFR are under 45 mL/min/1.73m2 (5)male or female subjects between 20-85 years of age at the time of informed consent (6)inpatient (7)ability to provide written informed consent
Exclusion criteria
Exclusion criteria: (1)history of allergy against this drug or similar compounds (2)patients who cannot feel thirsty or have difficulty to drink (3)patients who have difficulty to peroral drug administration (4)patients whose HF symptoms are remarkably unstable (5)patients who have circulation assist (6)patients who have disease, complication or symptom as follows; possibly hypovolemic *systolic blood pressure<90mmHg *hypertrophic cardiomyopathy *active myocarditis or amyloid cardiomyopathy *severe valvular cardiopathy *severe diabetes *body mass index (BMI)>35 *anuria (urine volume<100ml/day) *impairment of urinary excretion due to urinary stenosis, calculus or tumor *hepatic coma *subjects who are pregnant or possibly pregnant (7)patients who have a history as follows; *a history of sustained ventricular tachycardia or ventricular fibrillation in patients who do not have ICD *a history of cerebrovascular disease within 6 months (except for asymptomatic ischemic stroke ) *a history of acute myocardial infarction within 30 days (8)patients whose laboratory tests are as follows; *serum Na>147mEq/L *serum K>5.5mEq/L *T.B>3.0mg/dL (9)patients who are judged to be inappropriate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration, Cmax,AUC24h,AUCt, tmax, t1/2 of tolvaptan on day 1 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| urine volume, fluid intake, clinical laboratory tests of serum chemistry and urine chemistry, serum BNP, serum AVP, body weight, congestive symptom and safety | — |
Countries
Japan
Contacts
Public ContactYugo Shibagaki
St. Marianna University Hospital Renal Disease Integrated Care Center
Outcome results
None listed