Prognosis of Primary Aldosteronism: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Cumulative incidence of Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
Primary aldosteronism (PA) is the most common cause of secondary hypertension, and patients with PA have a significantly higher risk of developing cardiovascular and renal complications compared with those with essential hypertension. However, PA remains substantially underdiagnosed and undertreated in clinical practice, and relevant research data on the short-term and long-term prognosis of PA patients in the Chinese population are particularly scarce. This is a multicenter, prospective cohort study designed to systematically collect real-world clinical data of PA patients, including baseline clinical characteristics, etiological subtypes, diagnostic and therapeutic strategies, and long-term follow-up outcomes. Through 5 years of standardized follow-up, this study will analyze the differences in treatment efficacy among PA patients with different pathological subtypes (e.g., adrenal adenoma, adrenal hyperplasia), evaluate the short-term therapeutic efficacy and long-term prognosis of PA patients undergoing different treatment modalities including pharmacotherapy, surgery and interventional therapy, and explore the risk factors for adverse clinical outcomes. Ultimately, it will provide high-quality real-world evidence-based data to optimize the clinical diagnosis and management of PA and improve the long-term prognosis of affected patients.
详细描述
This study conducts long-term follow-up observations on patients with primary aldosteronism (PA), dynamically tracks changes in their condition, and systematically collects information related to treatment regimens and health outcomes, aiming to ultimately achieve the following research objectives: clarify the proportion and regularity of PA patients achieving normalization of both blood pressure and relevant hormonal levels after treatment (i.e., the status of "complete cure"); analyze differences in therapeutic efficacy among PA patients with different pathological subtypes such as adrenal adenoma and adrenal hyperplasia; evaluate the impact of different treatment modalities including pharmacotherapy, surgery and interventional therapy on patients' long-term health; observe the trajectory changes of PA-induced damage to the heart, kidneys and blood vessels, as well as metabolic and cognitive function abnormalities; and screen for key factors influencing patients' blood pressure control efficacy and the occurrence of cardiovascular and cerebrovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years old.
- •Biochemically confirmed diagnosis of Primary Aldosteronism (PA) according to contemporary guidelines (e.g., confirmed positive case detection test and confirmatory test).
- •Voluntary to sign the informed consent.
排除标准
- •patients with severe cardiac, hepatic or renal dysfunction;
- •Diagnosis of secondary hypertension other than PA.
研究组 & 干预措施
Primary Aldosteronism Group
Screened, confirmed and subtyped according to the guidelines.
结局指标
主要结局
Cumulative incidence of Major Adverse Cardiovascular Events (MACE)
时间窗: From study enrollment until the end of the 60-month follow-up period.
The proportion of patients who experience an adjudicated Major Adverse Cardiovascular Event (MACE), defined as a composite endpoint consisting of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death.
次要结局
- All-cause mortality(From study enrollment until the end of the 60-month follow-up period.)
- Blood pressure control rate(12, 24, 36, 48, and 60 months.)
- Incidence of new-onset atrial fibrillation (AF)(From study enrollment until the end of the 60-month follow-up period. Routine screening ECGs will be performed at 12, 24, 36, 48, and 60 months.)
- Incidence of cognitive impairment(Mild Cognitive Impairment or dementia)(12, 24, 36, 48, and 60 months.)
- Plasma Aldosterone Concentration (PAC)(Baseline, 12, 24, 36, 48, and 60 months.)
- Plasma Renin Concentration (PRC)(Baseline, 12, 24, 36, 48, and 60 months.)
- Serum Potassium (K+) Level(Baseline, 12, 24, 36, 48, and 60 months.)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline, 12, 24, 36, 48, and 60 months.)
- Urinary Albumin-to-Creatinine Ratio (UACR)(Baseline, 12, 24, 36, 48, and 60 months.)
- Left Ventricular Mass Index (LVMI)(Baseline, 12, 24, 36, 48, and 60 months.)
- Carotid Intima-Media Thickness (CIMT)(Baseline, 12, 24, 36, 48, and 60 months.)
研究者
Xiang Xie
Professor
Xinjiang Medical University