Heart Failure
Conditions
Interventions
Add Tolvaptan 7.5-15mg to the conventional therapy
Add furosemide up to 40mg to the conventional therapy
Sponsors
Kanagawa Aquaresis Investigators
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: insufficient despite the oral diuretics or loop diuretics equivalent to furosemide 40mg or more / renal impairment whose eGFR is under 45mL/min/1.73m2 / male and female over 20 years of age ( at the time of informed consent) / inpatient / ability to informed consent
Exclusion criteria
Exclusion criteria: subjects who already administered injected HF medications (including diueretics, inotropes and vasodilators), and who already use mechanical support (mechanical ventilator such as NIPPV, IABP, PCPS, hemodialysis and hemodiafiltration) / history of allergy against tolvaptan or similar compounds / anuria / subjects who cannot feel thirsty or have difficulty to drink / hyponatremia / subjects who are pregnant or possibly pregnant /subjects who already have tolvaptan at the time of randomization / acute coronary syndrome or those who are planned percutaneous coronary intervention / malignancy / patients who are judged to be inappropriate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight / Congestive symptoms / Renal function / Number of patients who were discontinued from the study due to meeting event criteria, duration from the start to the discontinuation, and discontinuation rate / Free water clearance | — |
Countries
Japan
Contacts
Public ContactKazuko Nakamura
Kanagawa Aquaresis Investigators Management office
Outcome results
None listed