Phase III study to evaluate the effect of balcinrenone/dapagliflozin in patients with heart failure and impaired kidney function

JRCT ID: jRCT2031240037

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure and Impaired Kidney Function
• Date of first enrollment: 30/04/2024
• Target sample size: 240
• Countries of recruitment: Australia,Japan,India,Japan,Malaysia,Japan,Philippines,Japan,South Korea,Japan,South Africa,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,Vietnam,Japan,Argentina,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Peru,Japan,United States,Japan,China,Japan,Austria,Japan,Bulgaria,Japan,Czech Republic,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan
• Study type: Interventional

Intervention(s)

Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

1. balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

2. balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

3. dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin

Outcome(s)

Primary Outcome

Time to first occurrence of any of the components of the composite of:
- CV death
- HF hospitalisation
- HF event without hospitalisation

Key inclusion & exclusion criteria

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

Include criteria

1. Age >= 18 years

2. Documented diagnosis of symptomatic HF (NYHA functional class II-V)

3. Having had a recent HF event within 6 months (hospitalization or urgent visit)

4. Have a LVEF value from an assessment within the last 12 months

5. Managed with SoC therapy for HF and renal impairment according to local guidelines

6. NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter)

7. Not taking an MRA

8. An eGFR >= 20 to < 60 mL/min/1.73 m2

9. Serum/plasma potassium >= 3.5 mmol/L and <= 5.0 mmol/L

Exclude criteria

1. Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months

2. Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or planned to undergo any of these operations

3. History of hypertrophic obstructive cardiomyopathy

4. Complex congenital heart disease or severe uncorrected primary valvular disease

5. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker

6. Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours

7. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of CO
PD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment

8. Type 1 diabetes mellitus

9. Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy

10. Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 x ULN; or TBL > 2 x ULN at time of screening

11. Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks

12. Treatment with strong or moderate CYP3A4 inhibitor or inducer

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06307652