Short term clinical efficacy and safety of Tolvaptan additional treatment compared with escalation treatment of conventional diuretics in HF patients with volume overload despite treatments with the conventional diuretics

Short term clinical efficacy and safety of Tolvaptan additional treatment compared with escalation treatment of conventional diuretics in HF patients with volume overload despite treatments with the conventional diuretics - Short term clinical efficacy and safety of Tolvaptan additional treatment compared with dose up conventional diuretics treatment in HF patients with volume overload despite the treatment with the conventional diuretics

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009136

Enrollment

Registered

2012-10-31

Start date

2012-10-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congestive heart failure

Interventions

Administered group of loop diuretics furosemide 40mg oral or equivalent Administered group of Torvaptan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who were diagnosed of heart failure. Patients with either congestive symptoms of dyspnea, pulmonary, congestion, pulmonary rale, third heart sound, juglar venous distention, lower limb edema. Patients who received loop diuretics at a daily dosage equivalent to 40 mg or more of furosemide. Male or female patients between the ages of 20 and 85, inclusive (at time of informed consent) Patients capable of giving informed consent to participate in the study of their own free will.

Exclusion criteria

Exclusion criteria: Patients with a history of hypersensitivity for an ingredient of tolvaptan or an analogue (Mozavaptan) Patients with anuria Patients who cannot feel thirst or are difficult to intake the fluid. Patients with hypernatremia. Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant. Patients who are diagnosed following diseases A) Serious coronary artery disease, cerebrovascular disease B) Hyperkalemia C) Serious Renal failure D) Diabetes mellitus with poorly controlled blood glucose E) Serious hepatic disorder F) Urinary excretion disorder in order to the stenosis of the urinary tract G) Valvular disease that in order to valvular stenosis is severe H) Malignant tumor Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Body weight change from baseline to day7 and day12 Body weight change from day12 to day14	—

Secondary

Measure	Time frame
Average urine volume from day1 to day7 Congestive symptoms Serum electrolyte concentration Serum creatinine concentration Neurohumoral factors	—

Countries

Japan

Contacts

Public ContactImai Masao

Kyoto University Hospital Cardiovascular internal medicine

m_imai@kuhp.kyoto-u.ac.jp075-751-4255

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026