Effect of diuretic management with tolvaptan on worsening heart failure of outpatients

Effect of diuretic management with tolvaptan on worsening heart failure of outpatients - Edematol-HF Pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240104

Enrollment

Registered

2024-05-23

Start date

2024-12-26

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 heart failure

Interventions

tolvaptan for 14 days orally (3.75 or 7.5mg/day for initial dose, can be increased to 15mg/day)

diuretic resistance, tolvaptan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HF patients with fluid retension despite use of high-dose loop diureatic agents (over furosemide 40mg/day or azosemide 60mg/day, torasemide 8mg/day) who meets these criteria 1. difficult to be managed by inpatient care (unable to obtain consent for hospitalization due to economic, social, or other problems), but SpO2 over 95% maintained in room air and amenable to outpatient management 2. BNP over 100 pg/mL or NT-proBNP over 300 pg/mL 3. age over 18 years old at the timing of written informed consent 4. male or female

Exclusion criteria

Exclusion criteria: 1. over 80 years old 2. Hypernatremia (serum Na over 146 mEq/L) 3. Hyponatremia (serum Na < 130 mEq/L) 4. LVEF < 20 % 5. Unable to visit according to the study protcol 6. severe kidney disfunction (eGFR under 15 mL/min/1.73m2 , auria or hemodialysis) 7. current use of tolvaptan 8. history or presence of severe hepatic disfunction (Child-puhg Classification C) such as chronic hepatitis or drug-induced hepatic dysfunction 9. fluid intake difficulties or lack of thirsty feeling 10. allergy for tolvaptan 11. pregnant, unwilling to practice contraception during the study, or lactating female 12. difficult to refrain from drinking alcohol during the study period 13. other (inappropriate for the study by the attending physician)

Design outcomes

Primary

Measure	Time frame
changes in body weight 14days after tolvaptan treatment	—

Secondary

Measure	Time frame
efficasy and safety 1. NYHA cllasification 2. BP, PR, SpO2, congestive signs and symptoms 3. renal function (creatinine, BUN, eGFR) 4. Worsening renal failure (serum creatinine >0.3mg/dL) 5. Na, K, Cl 6. BNP 7. CA125 8. chest X-ray (CTR, congestion and pleural effusion) 9. Hypernatremia (serum Na over 150 mEq/L) 10. heart failure hospitarization during study period 11. Urinalysis (Na, Cr, BUN, Osmolarity) 12. facial expression, voice	—

Measure

Time frame

efficasy and safety 1. NYHA cllasification 2. BP, PR, SpO2, congestive signs and symptoms 3. renal function (creatinine, BUN, eGFR) 4. Worsening renal failure (serum creatinine >0.3mg/dL) 5. Na, K, Cl 6. BNP 7. CA125 8. chest X-ray (CTR, congestion and pleural effusion) 9. Hypernatremia (serum Na over 150 mEq/L) 10. heart failure hospitarization during study period 11. Urinalysis (Na, Cr, BUN, Osmolarity) 12. facial expression, voice

—

Contacts

Public ContactYohei Hanajima

Yokohama City University Medical Center

hana0520@yokohama-cu.ac.jp+81-45-261-5656

Outcome results

None listed

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