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

JRCT ID: jRCTs031240104

Registered date:23/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart failure
• Date of first enrollment: 23/05/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): tolvaptan for 14 days orally (3.75 or 7.5mg/day for initial dose, can be increased to 15mg/day)

Outcome(s)

• Primary Outcome: changes in body weight 14days after tolvaptan treatment

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Okada Kozo