NCT06457074招募中4 期
Finerenone for Patients With Primary Aldosteronism (FAIRY): A Multicenter, Randomized Clinical Trial
Qifu Li1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2024年6月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Change from baseline in 24-hour SBP
研究概览
简要总结
Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).
详细描述
This is a multicenter, randomized study designed to evaluate efficacy and safety of finerenone in patients with PA. PA patients are randomly divided into two groups and treated with finerenone or spironolactone for 12 weeks. Spironolactone will be used as the control, while outcome will be assessed after 12-week treatment. Both drugs will be started at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Aged between 18-75, male or female;
- •. With confirmed PA diagnosis (screening positive and at least one confirmatory test is positive); NOTE: Screening positive was defined as plasma aldosterone-to-renin ratio (ARR)
- •≥ 20(pg/ml)/(μIU/ml) or ARR≥30(ng/dL)/(ng/ml/hr). Plasma aldosterone concentration (PAC) post captopril challenge test (CCT) ≥ 110 pg/ml or PAC post seated saline infusion test (SSIT) ≥ 80 pg/ml was considered positive. Note: ARR≥10(pg/ml)/(μIU/ml) or ARR≥15(ng/dL)/(ng/ml/hr) can be considered positive if the patients with hypokalemia (serum potassium < 3.5mmol/L) or adrenal nodules (diameter > 1cm).
- •. Not taking any antihypertensive drugs or on a stable regimen of antihypertensive agents(Limited to alpha-adrenergic receptor blockers and calcium channel blockers.) for more than four weeks before screening;
- •. With a mean seated office SBP≥140 or DBP≥90 mmHg;
- •. Able and willing to give informed consent for participation in the clinical study;
排除标准
- •Has a plan to conduct PA subtype classification(eg. Adrenal vein sampling, PET-CT) in 3 months；
- •Has planned surgery within 3 months;
- •With a mean seated office SBP ≥ 180mmHg or DBP ≥ 110mmHg before randomization; Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit. If the patient did not take their regularly scheduled antihypertensive medications prior to the visit, 1 BP re-test is allowed within 2 days after taking the medications.
- •Night shift workers;
- •Has a body mass index(BMI) ≥30 kg/m2 at screening;
- •Has uncontrolled diabetes with fasting blood glucose(FBG)≥13.3mmol/L at screening;
- •Has uncontrolled chronic diseases;
- •Has known other secondary hypertension (eg, renal artery stenosis, Cushing's syndrome, pheochromocytoma, or aortic coarctation) except subclinical Cushing's syndrome;
- •Has known and documented heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal;
- •Has had CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
- •Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
- •Has poor compliance that can not fully participating in the study;
- •Has hyperkalemia with serum potassium > 5.0mmol/L without potassium supplementation;
- •Has a history of uncontrolled malignant tumor;
- •Has more than 20mmHg difference of seated office SBP in both arms;
- •Is not willing or not able to stop taking sex hormones, glucocorticoids, non-steroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or antidepressants;
- •Is pregnant, breastfeeding, or planning to become pregnant during the study;
- •Complicated with severe mental illness;
- •Has had prior solid organ transplant and/or cell transplants;
- •Has a history of allergy to Finerenone or spironolactone;
- •Has typical consumption of ≥15 alcoholic drinks weekly. Note: 1 drink of alcohol is equivalent to 360ml beer, 45ml spirits, or 150ml wine;
- •Has participated in another clinical study involving any investigational drug within 30 days prior to screening；
- •Female of childbearing potential refuses to use non-hormonal contraception methods during the study period;
- •Refuse to stop eating grapefruit or grapefruit juice during treatment with Finerenone;
- •Other situations that the investigator assesses the subject as unable to complete the trial.
研究组 & 干预措施
Finerenone
Experimental
Patients divided into Finerenone group need to be treated with finerenone.
干预措施: Finerenone Oral Tablet (Drug)
Spironolactone
Active Comparator
Patients divided into Spironolactone group need to be treated with spironolactone.
干预措施: Spironolactone Oral Tablet (Drug)
结局指标
主要结局
Change from baseline in 24-hour SBP
时间窗: 12 weeks
Change from baseline in 24-hour systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
次要结局
- Change from baseline in nighttime DBP(12 weeks)
- Serum potassium(12 weeks)
- Plasma renin concentration(12 weeks)
- Change from baseline in nighttime SBP(12 weeks)
- Change from baseline in 24-hour DBP(12 weeks)
- Change from baseline in daytime SBP(12 weeks)
- Change from baseline in daytime DBP(12 weeks)
- Blood pressure control rate at the end of the study(12 weeks)
- Hypokalemia control rate at the end of the study(12 weeks)
研究者
Qifu Li
Primary investigator
Chongqing Medical University
研究点 (1)
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