Aldosterone Renin Ratio (ARR) Test to Increase Case-detection of Primary Aldosteronism (PA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Percentage of patients with Primary Aldosteronism (PA) that were missed.
研究概览
简要总结
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications.
详细描述
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications. It is caused by the autonomous secretion of aldosterone by the adrenal glands.
Hypertension, elevated adrenal aldosterone secretion, and suppressed renin are the hallmarks of PA. The prevalence of PA varies approximately from 5% up to 20%.
Clinicians continue to erroneously learn that PA is a very rare disorder, thus PA continues to be under-recognized and undertreated. PA is a major public health issue, and the current case-detection rate is much below the prevalence rates reported in studies. Correctly identifying PA in patients will enable effective treatment and potential cure for this disease Hypertension by itself is a major driver of cardiovascular morbidity and mortality. There are ~ 1 billion people diagnosed with hypertension in the world, and even if we take a conservative prevalence of PA of 5% amongst this population, it would yield a staggering number of 50 million.
Cardiovascular and cerebrovascular morbidity and mortality rates are higher in those with PA compared to patients with blood pressure-matched essential hypertension.
As per the current Endocrine Society Guidelines, only patients who meet specific clinical profiles are considered to be candidates for screening for PA. Typically screening involves a blood test for calculating aldosterone and renin ratio (ARR). An abnormal test indicates the possibility of PA. It is estimated that only 1% of patients are detected by these screening guidelines.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate in the study
- •Participants limited to subjects in the CCF
- •Age between and inclusive of 18 and 65 years of age
- •No gender exclusion
- •Patients diagnosed with Essential Hypertension by ICD-10 code on at least two occasions in the previous six months, even if not on medications for hypertension
- •Patients on a single anti-hypertensive medication for at least six months with the diagnosis of hypertension
排除标准
- •Those on a mineralocorticoid antagonist therapy (spironolactone, eplerenone)
- •Those with a documented diagnosis of primary aldosteronism or primary hyperaldosteronism
- •Those with a diagnosis of secondary hyperaldosteronism
- •Those with a diagnosis of heart failure, renal artery stenosis, cirrhosis, ascites, cor pulmonale.
- •Pregnancy status (verbal)
研究组 & 干预措施
Screening Cohort
This is a prospective specimen collection cohort study aimed to increase the detection of primary aldosteronism (PA) in patients with hypertension.
Study samples will be obtained longitudinally. One collection of plasma will be obtained. Blood draw may need to be repeated in some subjects after washout period. Study will continue for a period or 1 year, with plan to enroll around 50 subjects.
干预措施: Blood test for ARR (Procedure)
结局指标
主要结局
Percentage of patients with Primary Aldosteronism (PA) that were missed.
时间窗: 1 year
次要结局
未报告次要终点