Prospective Study on Primary Aldosteronism in Resistant Hypertension

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    100
  • sponsor
    University of Turin, Italy
Updated on 26 January 2021
cardiovascular disease
hypertension
aldosterone
diuretics
diuretic
primary aldosteronism
antihypertensive drugs
antihypertensive agents
hyperaldosteronism

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.

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.

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Hyperaldosteronism, Resistant Hypertension, Refractory Hypertension, Atrial Fibrillation (Pediatric), Dysrhythmia, Hypertensive End-Organ Damage, Aortic Ectasia, Hypertensive End-Organ Damage, primary hyperaldosteronism, aortic dilatation, primary aldosteronism, conn, Hypertensive End-Organ Damage
Clinical Study IdentifierNCT04213963
SponsorUniversity of Turin, Italy
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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