The Association Between Primary Aldosteronism and Cognitive Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- 1-Year Early Cognitive Progression in Patients with PA
研究概览
简要总结
The goal of this observational study is to learn about the prevalence, progression, and influencing factors of cognitive impairment in patients with primary aldosteronism (PA). The main questions it aims to answer are:
- What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it?
- What is the incidence of cognitive progression in PA patients within 1 and 5 years of follow-up and what factors influence this progression? Participants who are already diagnosed with PA as part of their regular medical care will be invited to join this long-term study. They will complete regular cognitive tests, medical check-ups, and questionnaires for up to 5 years. Some participants will also have optional blood tests and brain scans to help researchers understand the causes behind any cognitive changes.
详细描述
This is a prospective observational cohort study conducted in two tertiary hospitals. The main purposes are to investigate the prevalence and influencing factors of mild cognitive impairment (MCI) and dementia at baseline in patients with primary aldosteronism (PA), assess the incidence and influencing factors of cognitive progression within 1 and 5 years of follow-up, and compare exploratory biomarkers, such as plasma neurofilament light chain (NfL) and brain magnetic resonance imaging (MRI) measures, between PA patients with and without baseline cognitive impairment. Eligible patients will be followed up for 5 years, with regular cognitive function assessment, clinical indicator monitoring, and detection of relevant biomarkers and imaging indicators. The study aims to delineate the cognitive trajectory in PA and identify associated clinical and biological predictors.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Aged ≥ 40 years.
- •2. Biochemically confirmed diagnosis of Primary Aldosteronism (PA) according to contemporary guidelines (e.g., confirmed positive case detection test and confirmatory test).
- •3. Ability to understand and cooperate with comprehensive neuropsychological assessment.
- •4. Voluntary participation and provision of written informed consent.
排除标准
- •1. Significant visual, hearing, or motor impairment that prevents completion of cognitive testing.
- •2. History of major neurological disorders (e.g., stroke, Parkinson's disease, intracranial tumor, severe traumatic brain injury).
- •3. History of major psychiatric illness, intellectual disability, or current use of antipsychotic medications.
- •4. Diagnosis of secondary hypertension other than PA.
- •5. Unwillingness to participate by the patient or their legal representative.
结局指标
主要结局
1-Year Early Cognitive Progression in Patients with PA
时间窗: Baseline and 12 months.
Defined as the proportion of PA patients who experience cognitive progression within 1 year of follow-up. Cognitive progression includes three transitions: 1) Normal cognition → MCI; 2) Normal cognition → Dementia; 3) MCI → Dementia.The diagnostic criteria for MCI and dementia are based on the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (for MCI and dementia). All events are adjudicated by an independent endpoint committee.
5-Year Cumulative Incidence of Cognitive Progression in Patients with PA
时间窗: Baseline, 12, 24, 36, 48, and 60 months.
Defined as the proportion of PA patients who experience cognitive progression within 5 years of follow-up. Cognitive progression follows the same transitions and diagnostic criteria as the 1-year primary outcome (NIA-AA criteria). All events are adjudicated by an independent endpoint committee.
次要结局
- Baseline Prevalence of Cognitive Impairment (MCI or Dementia) in Patients with PA(Baseline)
- 3-year cumulative incidence of cognitive progression in patients with PA(Baseline, 12, 24, and 36 months.)
- Plasma Renin Concentration (PRC)(Baseline, 12, 24, 36, 48, and 60 months.)
- Longitudinal Change in Global Cognitive Function(Baseline, 12, 24, 36, 48, and 60 months)
- Change in Functional Activities Questionnaire (FAQ) total score(Baseline, 12, 24, 36, 48, and 60 months.)
- Change in Neuropsychiatric Inventory (NPI) Total Score(Baseline, 12, 24, 36, 48, and 60 months.)
- Office Blood Pressure Control Rate(12, 24, 36, 48, and 60 months.)
- 24-Hour Ambulatory Blood Pressure Control Rate(12, 24, 36, 48, and 60 months.)
- Plasma Aldosterone Concentration (PAC)(Baseline, 12, 24, 36, 48, and 60 months.)
- Serum Potassium (K+) Level(Baseline, 12, 24, 36, 48, and 60 months.)
- Serum Sodium (Na+) Level(Baseline, 12, 24, 36, 48, and 60 months.)
- Low-Density Lipoprotein Cholesterol (LDL-C) Level(Baseline, 12, 24, 36, 48, and 60 months.)
- Lipoprotein(a) (Lp(a)) Level(Baseline, 12, 24, 36, 48, and 60 months.)
- Fasting Plasma Glucose Level(Baseline, 12, 24, 36, 48, and 60 months.)
- Glycated Hemoglobin (HbA1c) 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.)
- Left Ventricular Ejection Fraction (LVEF)(Baseline, 12, 24, 36, 48, and 60 months.)
- Carotid Intima-Media Thickness (CIMT)(Baseline, 12, 24, 36, 48, and 60 months.)
- Plasma NfL Concentration (Sub-study)(Baseline, 12, 36, and 60 months.)
- White Matter Hyperintensity (WMH) Volume (Sub-study)(Baseline, 12, 36, and 60 months.)
- Cerebral Blood Flow (Sub-study)(Baseline, 12, 36, and 60 months.)
- Incidence of Major Adverse Cardiovascular Events (MACE)(Baseline, 12, 24, 36, 48, and 60 months.)
- All-cause mortality(Baseline, 12, 24, 36, 48, and 60 months.)
研究者
Xiang Xie
Professor
Xinjiang Medical University