Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
研究概览
简要总结
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.
详细描述
PA is the most frequent form of secondary hypertension, with a prevalence that increases with the severity of hypertension. The wide variation of the reported PA prevalence is due to different study design and population. Very few data derive from well designed prospective study. Additional problems in the interpretation of study results are the different diagnostic cut-off used in various centers and the low diffusion of the adrenal vein sampling, that has a central role in the PA diagnosis.
Resistant hypertension (RH) is a condition of insufficient BP control, despite appropriate lifestyle measures and treatment with at least 3 drugs at full dose, including a diuretic, in patients whose adherence to therapy has been confirmed. The primary aim of our study is define prospectively the prevalence of PA in RH.
Moreover, emerging evidence supports the crucial role of elevated serum aldosterone in promoting cardiovascular disease, independently from high BP levels. Aldosterone improves oxidative stress, inflammation, impairs insulin metabolic signaling, reduced endothelial-mediated vasorelaxation and is associated to cardiovascular and renal abnormalities. However, current data on the contribution of PA on cardiometabolic complications have heterogeneous results.
The secondary outcome of our study is to investigate prospectively the association of PA with cardiometabolic complications in a cohort of patients with RH.
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
- •age over 18 and under 80 years old;
- •diagnosis of resistant hypertension defined as: uncontrolled blood pressure at ambulatory blood pressure measurement (ABPM), despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic.
排除标准
- •age under 18 or over 80 years old;
- •pseudo-resistant hypertension (poor medication adherence, high salt intake);
- •previous cardiovascular disease;
- •insulin treated diabetes mellitus;
- •other than primary aldosteronism cause of secondary hypertension (obstructive sleep apnea, renal artery stenosis, pheochromocytoma/paraganglioma, primary hyperparathyroidism, autonomous cortisol secretion or over hypercortisolism);
- •liver cirrhosis;
- •chronic heart failure;
- •known malignant neoplasm;
- •chronic disease with major organ involvement;
- •excessive alcohol ingestion;
- •current steroids assumption;
- •use of sympathomimetic drugs;
- •use of contraceptives.
结局指标
主要结局
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
时间窗: Baseline.
Aldosterone (pg/mL) post saline infusion test, performed at baseline.
次要结局
- Insulin resistance in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension(Baseline.)
- Dyslipidemia in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Microalbuminuria in primary aldosteronism and essential resistant hypertension.(Baseline.)
- Aortic ectasia in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.(Baseline)
- Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Atrial fibrillation in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Sodium levels in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Potassium levels in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Oxidative stress in primary aldosteronism versus essential resistant hypertension.(Baseline.)
- Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.(Baseline.)
研究者
Mauro Maccario
Medical Doctor, Professor
University of Turin, Italy