NIPH Clinical Trials Search

Acute Effects of Tolvaptan on Acute Exacerbation of Chronic Heart Failure

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	heart failure
Date of first enrollment	2013/09/01
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional,observational
Intervention(s)	treatment with oral topvaptan treatment with carperitide and fulosemide injection

Outcome(s)

Primary Outcome

Average urinary volume in a day and body weight change, at fifth or the last day of the treatment

Secondary Outcome

1) NT-proBNP; before and fifth or the last day of the treatment 2) serum Na, K, creatinie; before and fifth or the last day of the treatment 3) IVC diameter by echocardiography; before and fifth or the last day of the treatment 4) urinary osmorarity; before and fifth or the last day of the treatment 5) oxidative stress marker change; serum and urine 6) event frequency during 90 days after hospital discharge 7) cost of heart failure treatment during hospital admission; cost of treatment or admission fee

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1) heart failure patient by coronary artery disease 2) patient who has allergic past history to tolvaptan or relative chemicals 3) patient of no urine production 4) patient who do not feel thirsty or have difficulty to take water orally 5) patient who is hypernatremia 6) patient who is pregnant or might be pregnant 7) patient who is very low blood pressure or cardiogenic shock state 8) patient who suffers right ventricular myocardial infarction 9) patient who have dehydration 10) patient who is assessed to be inappropriate for the study by study investigators