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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: Placebo of tolvaptan; Drug: Tolvaptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01439009

156-10-005

JapicCTI-111621 (Other Identifier)

Details and patient eligibility

About

One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

Enrollment: 100 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Tolvaptan

Experimental group

Description:

15 mg

Treatment:

Drug: Tolvaptan

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo of tolvaptan