Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.

Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial. - Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009810

Enrollment

180

Registered

2013-01-19

Start date

2012-11-01

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

Conventional therapy only Conventional therapy with 14 days administration of tolvaptan 7.5mg/day. Conventional therapy with 7 days administration of tolvaptan 15mg/day.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Congestive heart failure patients to administrating loop diuretics with volume overload in hospital.

Exclusion criteria

Exclusion criteria: 1) Patients who a history of hypersensitivity to tolvaptan 2) Patients with severe hypotention or cardioganic shock 3) Patients with cardiac assist device 4) Patients with dehydration 5) Patients with systolic blood pressure < 90mmHg 6) Patients with serum Na > 147 mEq/L or serum K > 5.5 mEq/L or T- bilirubin > 3.0 mg/dL 7)Patients considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

Measure	Time frame
The rate of change of serum creatinine	—

Secondary

Measure	Time frame
body weight, daily urine volume, dyspnea, congestive findings(leg edema, jugular vein dilatation, pulmonary congestion ), serum sodium, serum potassium, cystitis C, time to re-hospitalization.	—

Countries

Japan

Contacts

Public ContactYoshihiro kato

Saiseikai Noe hospital Department of cardiology

0669320401

Outcome results

None listed

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