A study to evaluate the safety and efficacy of tolvaptan in acute heart failure with hypoalbuminemia

A study to evaluate the safety and efficacy of tolvaptan in acute heart failure with hypoalbuminemia - A study to evaluate the safety and efficacy of tolvaptan in acute heart failure with hypoalbuminemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010307

Enrollment

Registered

2013-03-22

Start date

2013-03-22

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

Heart Failure

Interventions

Tolvaptan 3.75-15mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Heart failure patients with volume overload despite diuretics (2)ability of oral administration (3)male or female subjects over 20 years of age at the time of informed consent (4)ability to provide written informed consent

Exclusion criteria

Exclusion criteria: (1)history of allergy against this drug or similar compounds (2)anuria (urine volume <100ml/day) (3)subjects who cannot feel thirsty or have difficulty to drink (4)subjects whose serum sodium level is over 147mEq/L (5)subjects who are pregnant or possibly pregnant (6)serum creatinine>1.5mg/dL (7)subjects who already have tolvaptan at the entry (8)acute coronary syndrome (9)patients who are judged to be inappropriate to this study

Design outcomes

Primary

Measure	Time frame
Urine Output	—

Secondary

Measure	Time frame
Body Weight, Blood Pressure, Pulse, Laboratory Tests, Adverse Event	—

Countries

Japan

Contacts

Public ContactToshitaka Okabe

Showa University Northern Yokohama Hospital Division of cardiology and cardiac catheterization laboratory

alone_with_music@hotmail.com045-949-7000

Outcome results

None listed

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