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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Division of Endocrinology, Diabetology and Metabolism; University of Turin
Turin, Piedmont, Italy
RECRUITINGNumber of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Basal Aldosterone (pg/mL) at baseline.
Time frame: Baseline.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Basal Plasma Renin Activity (PRA, ng/mL/h) at baseline.
Time frame: Baseline.
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
Aldosterone (pg/mL) post saline infusion test, performed at baseline.
Time frame: Baseline.
Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension
Left ventricular mass evaluation with Echocardiogram at baseline.
Time frame: Baseline.
Microalbuminuria in primary aldosteronism and essential resistant hypertension.
Albuminuria/Creatininuria ratio (mg/mmoL) at baseline.
Time frame: Baseline.
Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.
Intima media thickness values (mm) evaluation with carotid Doppler ultrasound at baseline.
Time frame: Baseline
Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.
Serum creatinine (mg/dL) at baseline.
Time frame: Baseline.
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Aortic ectasia in primary aldosteronism versus essential resistant hypertension.
Aortic size (mm) determined with echocardiogram at baseline.
Time frame: Baseline.
Atrial fibrillation in primary aldosteronism versus essential resistant hypertension.
Electrocardiogram (ECG) at baseline.
Time frame: Baseline.
Insulin resistance in primary aldosteronism versus essential resistant hypertension.
Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.
Time frame: Baseline
Insulin resistance in primary aldosteronism versus essential resistant hypertension.
Oral glucose tolerance test (OGTT) for determination of insulin (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.
Time frame: Baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0' and 120' at baseline.
Time frame: Baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
HbA1c (mmol/mol) at baseline.
Time frame: Baseline.
Sodium levels in primary aldosteronism versus essential resistant hypertension.
Serum Sodium (mmol/L) at baseline.
Time frame: Baseline.
Potassium levels in primary aldosteronism versus essential resistant hypertension.
Serum Potassium (mmol/L) at baseline.
Time frame: Baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.
Blood determination of 8-isoprostane (UI/L) at baseline.
Time frame: Baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.
Blood determination of total antioxidant capacity (UI/L) at baseline.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum triglycerides (mg/dL) at baseline.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum total-Cholesterol (mg/dL) at baseline.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum HDL-Cholesterol (mg/dL) at baseline.
Time frame: Baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
Serum LDL-Cholesterol (mg/dL) at baseline.
Time frame: Baseline.