Congestive heart failure
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are currently on treatment with any of the following diuretics - Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher - Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose - Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose 2. Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present 3. Patients who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion criteria
Exclusion criteria: 1. Patients with acute heart failure 2. Patients who are on a ventricular assist device 3. Patients who are unable to sense thirst or who have difficulty with fluid intake
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory change in body weight from baseline at the time of final IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Proportion of responders in Lower Limb Edema and Pulmonary Congestion Change from baseline in jugular venous distension and hepatomegaly. Proportion of subjects who achieve resolution of pulmonary rales and third cardiac sound Changes in New York Heart Association classification | — |
Countries
Japan
Outcome results
None listed