NIPH Clinical Trials Search

FLEX-MRA trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Heart failure patients complicated by chronic kidney disease
Date of first enrollment	12/05/2026
Target sample size	180
Countries of recruitment
Study type	Interventional
Intervention(s)	Oral administration of finerenone(Kerendia)10 mg or 20 mg once daily for 12 weeks.

Outcome(s)

Primary Outcome	Absolute change in serum potassium levels from baseline (Timepoint 1) to Week 12 after switching to finerenone.
Secondary Outcome	1)Incidence of hyperkalemia(serum potassium > 6.5, > 6.0, > 5.5 mmol/L) 2)MRA discontinuation: Discontinuation rate of the study drug (MRA) 3)Changes in NT-proBNP: Absolute and percentage change in NT-proBNP from baseline to Week 12

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients aged greater than or equal to 20 years (male or female) at the time of informed consent. 2) Diagnosis of HF with most recent LVEF greater than or equal to 40% within the past 1 year 3) Outpatients without recent WHF within 4 weeks prior to informed consent (Events including the initiation or up-titration of HF therapies or diuretics.) 4) CKD (eGFR < 60 mL/min/1.73m2) by CKD-EPI Creatinine Equation (2021) within 2 weeks prior to informed consent 5) Spironolactone 25 or 50 mg/day for the management of HF at least 4 weeks at the time of informed consent. 6) For patients in sinus rhythm, NT-proBNP greater than or equal to 300 pg/mL (or BNP greater than or equal to 100 pg/mL) measured within 90 days prior to informed consent is required. These qualifying levels are tripled for patients with atrial fibrillation (i.e., NT-proBNP greater than or equal to 900 pg/mL or BNP greater than or equal to 300 pg/mL). 7) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol 8) Signed informed consent must be obtained prior to participation in the study
Exclude criteria	(Exclusion criteria at informed consent) 1) eGFR < 25 mL/min/1.73m2 by CKD-EPI Creatinine Equation (2021) at screening 2) Serum/plasma potassium > 5.0 mmol/L 3) Severe hypertension (SBP greater than or equal to 180 mmHg or DBP greater than or equal to 110 mmHg) or hypotension (SBP <80 mmHg) 4) History of stroke, acute coronary syndrome, acute myocarditis, or cardiac surgery within 90 days before informed consent 5) Any scheduled cardiac surgery 6) Presence of left ventricular assist device 7) Contraindications for finerenone -Patients with a history of hypersensitivity to the components of the study drug -Patients receiving treatment with any of the following: itraconazole, posaconazole, voriconazole, drugs containing ritonavir, atazanavir, darunavir, fosamprenavir, drugs containing cobicistat, clarithromycin, ensitrelvir, ceritinib, or lonafarnib. -Patients with serum potassium >5.5 mEq/L at the start of study drug administration -Hepatic insufficiency classified as Child-Pugh C -Addison's disease -Patients with severe renal impairment (eGFR <25 mL/min/1.73 m2) at the start of study drug administration 8) Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months) 9) Participation in another interventional clinical study (e.g. Phase 1 to 3 clinical studies) or treatment with another investigational medicinal product within 30 days prior to screening (Exclusion criteria during the run-in period (from obtaining informed consent to baseline)) 1)Use of potassium supplements or potassium binders 2)Serum potassium greater than or equal to 6.0 mmol/L 3)Occurrence of serious adverse events requiring hospitalization or out-of-hospital worsening heart failure events at baseline