Prospective Study on Primary Aldosteronism in Resistant Hypertension

Recruiting

• Conditions: Primary Aldosteronism; Aortic Ectasia; Hypertensive End-Organ Damage; Resistant Hypertension; Refractory Hypertension; Atrial Fibrillation

• Registration Number: NCT04213963
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-09-01
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-30
• Primary Completion: 2020-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.	Baseline.	Aldosterone (pg/mL) post saline infusion test, performed at baseline.

Secondary Outcome Measures

Name	Time	Method
Insulin resistance in primary aldosteronism versus essential resistant hypertension.	Baseline.	Oral glucose tolerance test (OGTT) for determination of insulin (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.
Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension	Baseline.	Left ventricular mass evaluation with Echocardiogram at baseline.
Dyslipidemia in primary aldosteronism versus essential resistant hypertension.	Baseline.	Serum LDL-Cholesterol (mg/dL) at baseline.
Microalbuminuria in primary aldosteronism and essential resistant hypertension.	Baseline.	Albuminuria/Creatininuria ratio (mg/mmoL) at baseline.
Aortic ectasia in primary aldosteronism versus essential resistant hypertension.	Baseline.	Aortic size (mm) determined with echocardiogram at baseline.
Oxidative stress in primary aldosteronism versus essential resistant hypertension.	Baseline.	Blood determination of total antioxidant capacity (UI/L) at baseline.
Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.	Baseline	Intima media thickness values (mm) evaluation with carotid Doppler ultrasound at baseline.
Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.	Baseline.	Serum creatinine (mg/dL) at baseline.
Atrial fibrillation in primary aldosteronism versus essential resistant hypertension.	Baseline.	Electrocardiogram (ECG) at baseline.
Sodium levels in primary aldosteronism versus essential resistant hypertension.	Baseline.	Serum Sodium (mmol/L) at baseline.
Potassium levels in primary aldosteronism versus essential resistant hypertension.	Baseline.	Serum Potassium (mmol/L) at baseline.
Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.	Baseline.	HbA1c (mmol/mol) at baseline.

Trial Locations

Locations (1)

Division of Endocrinology, Diabetology and Metabolism; University of Turin; 🇮🇹 Torino, Piemonte, Italy