Acute heart failure
Conditions
Interventions
Intravenous prodrug of tolvaptan 8 mg/ day, 3 days.
Oral tolvaptan 7.5 mg/ day, 3 days.
Sponsors
Izumi City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged 20 years or older admitted to Izumi City General Hospital with congestive heart failure and volume overload despite treatment with diuretics are included in this study. Only patients who received at least one month oral tolvaptan therapy before the hospitalization are enrolled. Also, patients have to be able to take oral tablets and water. Written informed consent prior to study participation were required.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKenji Matsumoto
Izumi City General Hospital Department of cardiology
Outcome results
None listed