Effect of tolvaptan prodrug in patients with acute heart failure who continue oral tolvaptan therapy
- Conditions
- Acute heart failure
- Registration Number
- JPRN-UMIN000047646
- Lead Sponsor
- Izumi City General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
Patients are excluded if they have a ventricular assist device, medical conditions that could be adversely affected by aquaretic treatment (e.g., hypovolemia, hypertrophic cardiomyopathy, valvular disease with significant valvular stenosis, hepatic encephalopathy or sepsis), difficulty in achieving adequate fluid intake, myocardial infarction within 30 days prior to screening, ventricular tachycardia or fibrillation within 30 days prior to screening, open heart surgery within 30 days prior to screening, poorly controlled diabetes, anuria, or dysuria with urinary tract obstruction, calculus, or tumor. Additional exclusion criteria are history of cerebrovascular disease (excluding asymptomatic cerebral infarction) within 6 months of screening; systolic blood pressure <90 mm Hg; serum/plasma creatinine >3 mg/ dL, serum/plasma sodium <125 mEq/ L or >147 mEq/ L, or serum/plasma potassium >5.5 mEq/ L; lactation or pregnancy; and any other reason which, in the opinion of the investigators, could endanger the patients or confound study analyses.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is the proportion of patients with at least moderate improvement in dyspnea by 7-point Likert scale at 6, 24 and 72 h after the randomization, without death or need for rescue therapy, and the improvement in the objective signs of congestion including jugular vein distension and leg edema.
- Secondary Outcome Measures
Name Time Method