Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial

Korábbi kezelés

• Major surgery under general anesthesia within 90 days before screening, or elective surgery planned within 90 days after screening.
• Active malignancy. Life expectancy \< 3 months. Use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) or inducers (e.g., rifampicin, carbamazepine, phenytoin) that cannot be discontinued within 7 days before Day 1.
• Use of mineralocorticoid receptor antagonists (e.g., finerenone, eplerenone, spironolactone), renin inhibitors, SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), or SGLT-1/2 inhibitors (e.g., canagliflozin) within 8 weeks before screening or during the intervention period.
• Participation in a clinical trial of empagliflozin or finerenone within 1 month before screening.
• Current use of weight-loss medications (e.g., GLP-1 receptor agonists, GIP/GLP-1 dual agonists, GLP-1/GCGR dual agonists) or prior/planned bariatric surgery.

Más betegség

• Acute coronary syndrome, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) within 90 days.
• Stroke or transient ischemic attack (TIA) within 90 days. Known secondary hypertension (e.g., bilateral renal artery stenosis \>75%, aldosteronism, pheochromocytoma), except documented sleep apnea.
• Gastrointestinal surgery or disease that, in the investigator's judgment, may affect absorption of the study drug.
• Known or suspected orthostatic hypotension or autonomic dysfunction. Any condition that, in the investigator's opinion, makes the participant unsuitable for the study.

Laborértékek

• Diastolic blood pressure ≥ 100 mmHg. Diagnosed diabetes mellitus or fasting plasma glucose ≥ 7.0 mmol/L. History of heart failure (any ejection fraction) or left ventricular ejection fraction \< 50%.
• Severe hepatic dysfunction (AST/ALT \> 3× upper limit of normal, or Child-Pugh class C).
• Acute kidney injury within 6 months before screening, or eGFR \< 60 mL/min/1.73 m², or kidney transplant (or planned).
• Primary adrenal insufficiency (Addison's disease). Contraindications to any component of the study drugs (e.g., urinary tract infection within 90 days, serum potassium \> 5.0 mmol/L, drug allergy).
• Use of potassium supplements, potassium-sparing diuretics (e.g., amiloride, triamterene), or potassium-binding agents within 8 weeks before screening or during the intervention period.

Egyéb

• Pregnancy, lactation, or planned pregnancy (for both male and female participants) during the study period.

• Age ≥ 40 years.
• Body mass index (BMI) ≥ 28 kg/m² or abdominal obesity, defined as meeting any of the following:
• Waist circumference ≥ 90 cm (male) or ≥ 85 cm (female); Waist-to-hip ratio ≥ 0.9 (male) or ≥ 0.85 (female); Waist-to-height ratio ≥ 0.5. Unattended office systolic blood pressure (SBP) ≥ 140 mmHg and \< 160 mmHg during the screening period (within 1 week before randomization).
• Currently taking no more than 2 antihypertensive agents (fixed-dose combinations are counted by the number of active ingredients).
• No changes in the type or dose of antihypertensive medications within 4 weeks before the screening visit.
• Provide written informed consent.