Clinical study of MINNEBRO

JRCT ID: jRCTs071240092

Registered date:27/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation, Hypertension
• Date of first enrollment: 27/12/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

- Normally, in adults, eplerenone is administered orally at a dose of 2.5 mg once daily. If the effect is insufficient, the dose may be increased up to 5 mg.
- For diabetes mellitus with moderate renal impairment (eGFR 30-60 mL/min/1.73m2) and albumin or proteinuria, start at 1.25 mg of esaxerenone.

Outcome(s)

• Primary Outcome: The number of days until atrial fibrillation recurrence (excluding the blanking period recurrence).

Secondary Outcome

- Left ventricular ejection fraction at 12 months after catheter ablation.
- The change in left atrial diameter from baseline at 12 months after catheter ablation.
- The change in creatinine clearance from baseline at 12 months after catheter ablation.
- The occurrence of cardiovascular events (heart failure, stroke, and other cardiovascular events requiring hospitalization) up to 12 months after catheter ablation.
- The overall mortality rate and the presence of cardiovascular-related deaths up to 12 months after catheter ablation.
- The presence or absence of subjective symptoms at 12 months after catheter ablation.
- The presence or absence of early recurrence during the blanking period.
- The achievement of blood pressure target at 12 months after catheter ablation.
- AF burden on Holter ECG at 12 months after catheter ablation.(Cumulative daily duration of AF, expressed as %.)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Patients providing written informed and consent to participate in the study.
2) Targeting patients diagnosed with atrial fibrillation (AF) who are scheduled for catheter ablation therapy, specifically focusing on those with poorly controlled hypertension. Note that the type of AF (paroxysmal or persistent) is not specified.
- The criteria for defining poorly controlled are as follows.
A patient with AF who is on anticoagulant therapy and whose average home blood pressure over one week is not achieving less than 125/75 mmHg.
3) Men and women aged 18 years or older, up to 85 years old, at the time of consent acquisition.

Exclude criteria

1) Patients with a history of AF ablation or cardiac surgery (open-heart surgery).
2) Patients with AF lasting > 3 years.
3) Patients with a left atrial anterior-posterior diameter of > 55 mm.
4) Patients taking maximum dose calcium channel blocker.
5) Patients who are already taking esaxerenone, spironolactone, or eplerenone.
6) Patients with allergies to esaxerenone or calcium channel blocker.
7) Patients with hyperkalemia or a patient whose serum potassium level exceeds 5.0 mEq/L at the initiation of this medication.
8) Patients with severe renal impairment (eGFR less than 30 mL/min/1.73m2).
9) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breast-feeding.
10) Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
11) Patients whom physician in charge considered inappropriate.

Related Information

• Primary Sponsor: Ninomiya Yuichi