Yokohama Heart Failure Investigators:Time Zone Dynamics of Serum Arginine-Vasopressin and Urine Aquaporin-2 on Acute Decompensated Heart Failure in the Patients with Depressed Left Ventricular Function

UMIN ID: UMIN000018717

Registered date:19/08/2015

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute congestive heart failure
• Date of first enrollment: 2015/02/01
• Target sample size: 16
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

tolvaptan morning administering group: Tolvaptan is administered in the morning from the third through fifth in-hospital day (3days)
tolvaptan before-sleep administering group: Tolvaptan is administered before sleep from the third through fifth in-hospital day (3days)

Outcome(s)

• Primary Outcome: urine volume per 6 hours
• Secondary Outcome: Relationship between urine AQP2, serume AVP and diuresis effect of tolvaptan

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)patient with acute heart failure presenting clinical scenarios 3, 4, and 5 2)patient to whom tolvaptan has already been administered 3)patient to whom continuous intravenous infusion inotropes (catecholamine, phosphodiesterase-3 inhibitors, colforsin daropate hydrochloride, etc) has already been administered or is planned to be administered 4)patient who has received mechanical support (invasive mechanical ventilation, intraaortic balloon pumping, percutaneous cardiopulmonary support, continuation hemofiltration-dialysis, etc.) or is planned to use it 5)patient who presents shock at enrollment 6)Patient with advanced renal dysfunction (eGFR<30ml/min/1.73m2) 7)patient who is judged to be improper by the doctor in charge

Related Information

• Primary Sponsor: National Hospital Organization Yokohama Medical Center
• Source(s) of Monetary Support: Clinical Research Devision, National Hospital Organization Yokohama Medical Center