Prospective Study on Primary Aldosteronism in Resistant Hypertension

Last updated: November 2, 2020
Sponsor: University of Turin, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Blood Pressure (Hypertension - Pediatric)

Circulation Disorders

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT04213963
The PrePARe Study
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age over 18 and under 80 years old;
  • diagnosis of resistant hypertension defined as: uncontrolled blood pressure atambulatory blood pressure measurement (ABPM), despite the use of at least 3antihypertensive drugs at full dose, including a diuretic.

Exclusion

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 sleepapnea, renal artery stenosis, pheochromocytoma/paraganglioma, primaryhyperparathyroidism, 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

Total Participants: 100
Study Start date:
September 01, 2011
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Division of Endocrinology, Diabetology and Metabolism; University of Turin

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

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