Tofogliflozin's effect to prevent - renal dysfunction mediated by Renal congestion Improvement in Subjects with diabetes mellitus-complicated heart failure; multicenter, open-label, Two-Arm Randomized-controlled trial

JRCT ID: jRCTs051240219

Registered date:19/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diabetes mellitus, heart failure, renal congestion
• Date of first enrollment: 21/01/2025
• Target sample size: 64
• Study type: Interventional

Intervention(s)

SGLT2 inhibitor add-on group
Administer tofogliflozin 20 mg/day, in addition to the medical agents used at giving their consent.
Dose of loop diuretics used at giving their consent will not be changed.
In principal, other medical agents will not be added or discontinued, or dose or usage of other medical agents used at giving their consent will not be changed.

Loop diuretics dose increase group
Increase the dose of loop diuretics used at giving their consent (20 mg increase in furosemide or 30 mg increase in azosemide).
In principal, other medical agents will not be added or discontinued, or dose or usage of other medical agents used at giving their consent will not be changed.

Outcome(s)

• Primary Outcome: Change in body weight from visit 1 (baseline) to visit 2 (week 6)

Secondary Outcome

1. Change in following items from visit 1 (baseline) to visit 2 (week 6)
i) Renal venous stasis index (RVSI)
ii) Intrarenal venous flow (IRVF)
iii) Ratio of central venous pressure and RVSI

2. Change in body weight stratefied by dose of diuretic agents

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study:
1. Patients with type 2 diabetes mellitus
2. Patients who use loop diuretic (furosemide or azosemide) of less than the maximum dose (furosemide: 80 mg/day, azosemide: 60 mg/day)* for at least 4 weeks til giving their consent
3. Patients with BNP of 100 pg/mL or higher at giving their consent
4. male and female aged 18 years or older at giving their consent
5. patients who provide their consent in a written form
*Patients who use both loop diuretics at least one of which is less than the maximum dose can participate in this study.

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1. Patients who had used SGLT2 inhibitor within 8 weeks before giving their consent
2. Patients with hisotory of hypersensitivity against SGLT2 inhibior
3. Patients who are using loop diuretics other than furosemide or azosemide at giving their consent
4. Patients who had received intravenous injection of loop diuretics within 4 weeks before giving their consent
5. Patients whose eGFR is less than 15ml/min/1.72m2, or patients who are treated by dialysis
6. Patients who are pregnant or planning to be pregnant during the participation period in this study
7. Patients who are treated for malignant neoplasm
8. Patients with poor adherence judged by the responsible investigator or subinvestigator
9. Patients who require legal representative to give their consent
10. Patients with other conditions that the responsible investigator or subinvestigator thinks inappropriate to participate in this study

Related Information

• Primary Sponsor: Kusaba Tetsuro
• Secondary Sponsor: Matoba Satoaki
• Source(s) of Monetary Support: Kowa Company, Ltd.