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

Inclusion Criteria:

• Patients from whom informed consent has been properly obtained in writing prior to start of the trial
• Patients who have been clinically diagnosed with heart failure
• Patients with any of the following conditions or symptoms: lower limb edema, dyspnea, jugular venous distension, hepatomegaly, pulmonary rales, third heart sound, or pulmonary congestion
• Patients who have been receiving loop diuretics, thiazide diuretics, or anti-aldosterone diuretics
• Male or female patients of age 20 to 85 years inclusive (at time of informed consent)
• Patients who, together with their partner(s), are able to use an appropriate method of contraception until 3 months after final trial drug administration
• Patients who are able to be hospitalized at the trial site for at least 7 days from the start of trial drug administration

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