Clinical trial NCT04213963: Prospective Study on Primary Aldosteronism in Resistant Hypertension
Official title: Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Resistant Hypertension
Primary Aldosteronism
Refractory Hypertension
Hypertensive End-Organ Damage
Atrial Fibrillation
Aortic Ectasia
Keywords: Resistant Hypertension
Primary Aldosteronism
Renin-Angiotensin System
Blood Pressure
Cardiometabolic Risk
Early Atherosclerotic Damage
Oxidative Stress
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 100 consecutive patients with age over 18 and under 80 years old and resistant hypertension (defined as uncontrolled blood pressure despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic) referred to the center for diagnosis and treatment of Hypertension (Division of Endocrinology, Diabetology and Metabolism, University of Turin) between March 2011 and July 2020.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
timeFrame: Baseline.
measure: Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
timeFrame: Baseline.
measure: Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.
timeFrame: Baseline.
Secondary outcomes:
measure: Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension
timeFrame: Baseline.
measure: Microalbuminuria in primary aldosteronism and essential resistant hypertension.
timeFrame: Baseline.
measure: Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline
measure: Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Aortic ectasia in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Atrial fibrillation in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Insulin resistance in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline
measure: Insulin resistance in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Sodium levels in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Potassium levels in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Oxidative stress in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Oxidative stress in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
measure: Dyslipidemia in primary aldosteronism versus essential resistant hypertension.
timeFrame: Baseline.
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Division of Endocrinology, Diabetology and Metabolism; University of Turin
state: Piemonte
Study officials:
affiliation: Endocrinology, Diabetology and Metabolism; University of Turin
name: Mauro M Maccario, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology, Diabetology and Metabolism; University of Turin
name: Ezio E Ghigo, MD
role: STUDY_CHAIR
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