Efficacy and safety of combination therapy with tolvaptan and dapagliflozin in patients with acute decompensated heart failure: A randomized controled trial

Efficacy and safety of combination therapy with vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure: A randomized controled trial - Combination therapy of vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039340

Enrollment

Registered

2020-01-31

Start date

2020-02-01

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

Acute decompensated heart failure

Interventions

Tolvaptan alone therapy Combination therapy with tolvaptan and dapagliflozin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: At admission by Acute decompansated heart failure Patients with diabetes mellitus Patients without tolvaptan and SGLT2 inhibitor administration Patients with preserved renal function (eGFR > 30)

Exclusion criteria

Exclusion criteria: Patients with acute coronary syndrome Patients with out-of-hospital cardiac arrest No tolerability of tolvaptan or dapagliflozin Rejected study enrollment

Design outcomes

Primary

Measure	Time frame
Comparison of 72 hours total urine output between tolvaptan alone therapy vs. combination therapy with tolvaptan and dapagliflozin	—

Secondary

Measure	Time frame
Akute kidney injury during hospitalization Dose of furosemide at discharge	—

Countries

Japan

Contacts

Public ContactShinobu Bando

Kansai Medical University Medical Center Department of Cardiology

bandoshi@takii.kmu.ac.jp0669921001

Outcome results

None listed

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