Renal Outcome in High Risk of Kidney Failure in Heart Failure Patient With and Without Tolvaptan, Randomized Controlled Trial

Phase 3

• Conditions: heart failure patient; high risk of kidney failure; heart failure patient with high risk of kidney failure; kidney outcome; tolvaptan

• Registration Number: TCTR20220701005
• Lead Sponsor: avamindradhiraj University Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study Completion: 2024-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.hospitalized heart failure patient
2.chronic kidney disease stage 3-4
3.in case of absence baseline renal function
3.1 patient with creatinine more than or equal 2mg/dl at admission
3.2 patient with creatinine 1.1 to less than 2mg/dl at admission with equal or more than 70 years old
4.more than 18 years old

Exclusion Criteria

1.Acute Kidney Injury Network stage 3 on admission
2.autosomal dominant polycystic kidney disease
3.pregnancy or breast feeding
4.cirrhosis or liver failure or transaminitis which AST, ALT more than 2times of upper normal limit
5.serum sodium more than 145mEq/L
6.concomitant use with CYP3A inhibitor such as ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, indinavir, ritonavir, diltiazem, verapamil
7.concomitant use with CYP3A inducer such as rifampin, barbiturate, phenytoin, carbamazepine
8.concomitant use with P-gp inhibitor such as cyclosporin
9.history of drug allergy with tolvaptan or furosemide
10.unstable vital sign
11.postcardiac arrest
12.unable to access tolvaptan within 24 hours after admission

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite kidney outcome 7 days creatinine, treatment with kidney replacement therapy, death

Secondary Outcome Measures

Name	Time	Method
incidence of acute kidney injury 7 days creatinine,incidence of kidney replacement therapy 7 days treatment with kidney replacement therapy,incidence of death 7 days number of death,incidence of hyponatremia, hypokalemia 7 days serum sodium, serum potassium,urine volume 7 days urine volume,dose of furosemide 7 days furosemide dose,composite congestion score 7 days composite congestion score