Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients

Exclusion Criteria

• •Patients with a history of hypersensitivity to any ingredient of the drug or to tolvaptan analogues (e.g., mozavaptan hydrochloride)
• •Patients with anuria
• •Patients who cannot sense thirst or who have difficulty with fluid intake
• •Patients with hypernatremia (serum sodium concentration \> institutional upper limit of normal) 5) Female patients who are pregnant, possibly pregnant, or nursing
• •Patients judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial due to any of the following conditions or symptoms:
• •* Hyponatremia (serum sodium concentration \< 125 mEq/L)
• •* Serious coronary artery disease or cerebrovascular disease
• •* Hyperkalemia
• •* Severe renal disorder
• •* Poorly controlled diabetes mellitus
• •* Severe hepatic disease
• •* Impaired urinary excretion due to urinary stenosis, calculus, or tumor
• •* Cardiac valve disease with significant heart valve stenosis
• •* Malignant tumor of unfavorable prognosis
• •Patients with suspected hypovolemia
• •Patients with an implanted circulatory support device
• •Patients in whom acute cardiac infarction occurred within 30 days prior to the screening examination
• •Patients who participated in any other clinical trial or postmarketing clinical trial within 30 days prior to the date of informed consent for the present trial
• •Patients who received tolvaptan within 26 weeks prior to the date of informed consent
• •Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial