An open-label, prospective randomized trial to assess the non-inferiority of diuretic effect of tolvaptan as an alternative agent to loop diuretics in chronic heart failure.

Not Applicable

• Conditions: chronic heart failure

• Registration Number: JPRN-UMIN000026331
• Lead Sponsor: Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University, Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-01
• Study Completion: 2020-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who have already received tolvaptan therapy. Patients who are more than 80 years and have difficulty in complain thirst. 2. Patients with renal dysfunction having an estimated glomerular filtration rate 30mL or less /min/1.73m2 and/or requiring hemodialysis. 3. Patients with liver dysfunction which is defined as an increase threefold in aspartate aminotransferase and/or alanine aminotransferase compared to the upper limit of normal range. 4. Patients with percutaneous coronary intervention or open heart surgery within the past 3 months. 5. Patients under the pacing therapy using implantable cardiac pacemaker, cardiac resynchronization therapy device, or implantable cardiac defibrillator. 6. Patients with type 1 diabetes mellitus. 7. Patients with endocrine diseases such as thyroid dysfunction, or adrenal dysfunction which may have an effect on balance of body fluid. 8. Patients with any serious non-cardiovascular disease including malignancy, which have expected 6 months or less to live. 9. Patients without agreement on enrolment of this trial through written texts.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in BNP levels from the enrolment in this trial to 2 months later.

Secondary Outcome Measures

Name	Time	Method
1) Changes in renal functional parameters: creatinine clearance, urinary microalbumin excretion, and urinary L-FABP excretion, from the enrolment in this trial to 2 months later. 2) Adverse events which are defined as all cause death, worsening of heart failure requiring an increase in an amount of loop diuretics, and ventricular arrhythmia which need cardioversion or defibrillation, during the period from the enrolment in this trial to 2 months later. 3) Adverse events which are defined as cardiovascular death and/or hospitalization for heart failure during 6 months after 2 months intervention period.