Water and Electrolytes Content in HYpertension (WHYSKI) in the SKIn

Launched by UNIVERSITY HOSPITAL PADOVA · Oct 18, 2023

Keywords

ClinConnect Summary

The WHYSKI trial is studying how certain substances in the skin, like sodium and potassium levels, change in patients who have high blood pressure due to a condition called primary aldosteronism. This condition can sometimes be treated with surgery. The researchers want to see if there are differences in these levels between patients with primary aldosteronism, those with essential hypertension (high blood pressure without a specific cause), and healthy individuals.

To be eligible for the trial, participants need to be between 18 and 75 years old and must provide written consent to join. Those with primary aldosteronism should have specific hormone test results confirming their diagnosis, while participants with essential hypertension need to be taking blood pressure medication or have high readings confirmed by monitoring. Healthy control participants should have normal blood pressure without any medication. If you join the study, you may undergo skin tests and blood pressure monitoring. This research aims to better understand how these factors in the skin relate to high blood pressure and could help improve treatment options in the future.

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Eligibility criteria

• Inclusion Criteria:
• • PA Group
• • Age: 18-75-year-old.
• • Signed informed consent form.
• • A diagnosis of PA defined as
• • o Plasma aldosterone concentration \> 15 ng/dL and aldosterone/renin ratio greater than 20.6 ng/mIU, measured after washout of interfering drugs or after changes of the drug treatment as previously detailed.
• • Unilateral or bilateral evidence of PA at adrenal vein sampling
• • PH Group
• • Age: from 18 to 75 years old
• • Signed and dated informed consent form
• * Diagnosis of essential hypertension defined either as:
• • Use of antihypertensive drug (s)
• • Arterial hypertension: in untreated patients this must be confirmed by daytime ambulatory blood pressure monitoring (ABPM), or home blood pressure monitoring, with blood pressure higher or equal to 135 mmHg for systolic blood pressure and/or higher or equal to 85 mmHg for diastolic blood pressure.
• • Exclusion of secondary hypertension by hormonal biochemical screening (aldosterone, renin, ARR\<2.06 ng/dL:mIU/L, ACTH, 24h urine cortisol, morning plasma cortisol level, 24h urine metanephrines and catecholamines).
• • Control Group
• • Age: from 18 to 75 years old
• • Signed and dated informed consent form
• * Normal arterial blood pressure defined either as:
• • None anti-hypertensive drug (s)
• • Normal arterial hypertension confirmed by daytime ambulatory blood pressure monitoring (ABPM), or home blood pressure monitoring, with blood pressure lower or equal to 135 mmHg for systolic blood pressure and/or lower or equal to 85 mmHg for diastolic blood pressure.
• • Exclusion of secondary hypertension by hormonal biochemical screening (aldosterone, renin, ACTH, 24h urine cortisol, morning plasma cortisol level, 24h urine metanephrines and catecholamines).
• Exclusion Criteria:
• • PA Group
• • history of allergy/intolerance to local anesthesia;
• • refusal of the patient to undergo skin biopsy;
• • refusal of the patient to undergo AVS, and/or contraindications to the general anesthesia that is required for laparoscopic adrenalectomy and/or to undergo adrenalectomy if indicated;
• • cortisol-aldosterone co-secreting adenoma or pheochromocytoma. PH Group and Control Group
• • Concurrent skin diseases, for example psoriasis, and any pathological conditions that, in the judgement of the investigators, could affect skin electrolyte and water content.
• • Subjects with diabetes mellitus type 1 and 2, as drugs affecting the renin-angiotensin-aldosterone system and/or renal Na+ handling as, for example, SGLT-2 inhibitors (gliflozins) 16 were considered to potentially bias results.
• • Other conditions characterized by possible lymphatic disruption such as lipedema, cyclic idiopathic edema, lymphedema, and malignancies were also exclusion criteria.