Examining Water and Electrolyte Changes in Hypertension
The Water and Electrolytes Content in Salt-dependent Human HYpertension (WHYSKI) in the SKIn Before and After Surgical Cure of Primary Aldosteronism
This study is trying to see how changes in sodium, potassium, and water in the skin affect high blood pressure in people with primary aldosteronism before and after they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital Padova Academic / other |
| Locations | 1 site (Padova) |
| Trial ID | NCT06090617 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how sodium, potassium, and water content in the skin are altered in patients with primary aldosteronism, a condition that causes salt-dependent hypertension. By analyzing skin biopsies before and after surgical treatment, the study aims to understand the relationship between these electrolyte changes and hypertension. Participants will undergo video-laparoscopic adrenalectomy after being treated with a mineralocorticoid receptor antagonist to manage their condition. The findings could provide insights into the pathophysiology of hypertension and the effectiveness of surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 diagnosed with primary aldosteronism or essential hypertension.
Not a fit: Patients with secondary hypertension not related to primary aldosteronism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with primary aldosteronism and related hypertension.
How similar studies have performed: While similar studies have explored electrolyte changes in hypertension, this specific approach focusing on skin biopsies in primary aldosteronism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Padova
- Azienda Ospedale Università di Padova — Padova, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.