Effect of Mineralcorticoid Recept Antagonist on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia：A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Occurrence of the composite endpoint
研究概览
简要总结
Elevated aldosterone causes moderate to severe increase in blood pressure, and leads to various target organ damage including cardiovascular ones. Aldosterone has been considered one of the important risk factors for cardiovascular and cerebrovascular diseases. Currently, the use of mineralocorticoid receptor antagonists(MRA) has been proven to reduce blood pressure levels, but long-term prognostic data are lacking in hypertensive patients. Therefore, the purpose of this clinical trial is to assess the effect of MRA on cardiovascular disease in patients with Hypertension and Hyperaldosteronemia.
详细描述
The trial will randomize about 7800 participants aged between 30 and 75 years with Hypertension and Hyperaldosteronemia(Plasma aldosterone concentration >12 ng/dl). All participants were randomly assigned to two different intervention groups. One group was treated with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in addition to the original antihypertensive drugs. One group was given the original antihypertensive drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old;
- •Blood pressure ≥140/90 mmHg, or have taken antihypertensive drugs;
- •Plasma aldosterone concentration> 12ng/ dL;
- •Serum potassium < 4.8mmol/L;
- •Signed the written informed consent.
排除标准
- •SBP/DBP≥190/120mmHg, DBP<60 mmHg;
- •Known secondary cause of hypertension, including pheochromocytoma, primary aldosteronism (adrenal tumor > 1cm), Cushing's syndrome, renal artery stenosis, renin tumor, connotation of aorta, etc.;
- •History of ischemic or hemorrhagic stroke within the last 3 months (not lacunar infarction and transient ischemic attack [TIA]).
- •History of Hospitalization for myocardial infarction or unstable angina, or coronary revascularization (PCI or CABG) within the last 3 months.
- •History of aortic dissection/dissection aneurysm rupture.
- •History of NYHA Grade III-IV heart failure or hospitalization Aggravated chronic heart failure upon admission within the last 3 months.
- •A history of persistent atrial fibrillation, atrial flutter, or other severe arrhythmias on admission (including sinus delay, diseased sinus, high atrioventricular block, frequent ventricular morning, etc.).
- •Severe liver disease or liver dysfunction: AST, ALT, or ALP > 5ULN (5 times the upper limit of normal), or BIL > 3ULN (3 times the upper limit of normal).
- •End-stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) <30 mL/min, or serum creatine >2.5 mg/dl [>221 umol/L];
- •Patients with serious physical diseases such as malignant tumors and autoimmune diseases.
- •Severe cognitive or mental impairment.
- •Pregnant and lactating women.
- •Those who have contraindications or allergies to MRAs.
- •Patients with hypoadrenocortical function.
- •Participating in other clinical trials.
研究组 & 干预措施
Mineralocorticoid Receptor Antagonists(MRAs)
Participants will treat with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in addition to the original antihypertensive drugs for 48 months.
干预措施: Mineralocorticoid Receptor Antagonists(MRAs) (Drug)
Blank Control
Participants will be given the original antihypertensive drugs for 48 months.
干预措施: Blank control (Other)
结局指标
主要结局
Occurrence of the composite endpoint
时间窗: 4 years
A composite endpoint comprised of occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass grafting \[CABG\]), atrial fibrillation, aortic dissection and dissection aneurysm, and death from cardiovascular causes.
次要结局
- Occurrence of Decline in renal function or development of end stage renal disease (ESRD)(4 years)
- Occurrence of cardiac adverse events(Acute coronary syndrome and coronary revascularization)(4 years)
- Occurrence of Atrial fibrillation(4 years)
- First occurrence of diabetes mellitus(4 years)
- Occurrence of symptomatic stroke ( ischemic or hemorrhagic)(4 years)
- First occurrence of nonalcoholic fatty liver(4 years)
- Occurrence of Decline in cognitive function(4 years)
- Occurrence of aortic dissection and dissection aneurysm(4 years)
- Occurrence of Hospitalization for acute decompensated heart failure(4 years)
- Occurrence of all-cause death(4 years)
- Changes in urine protein from baseline(1-4 years)
- Changes in cardiac structural indicators from baseline(1-4 years)
- Changes in vascular elasticity from baseline（ABI and baPWV）(1-4 years)
- Blood pressure control rate(1-3months)
研究者
Nanfang Li
Professor, Chief physician
People's Hospital of Xinjiang Uygur Autonomous Region