Status:
RECRUITING
Water and Electrolytes Content in HYpertension (WHYSKI) in the SKIn
Lead Sponsor:
University Hospital Padova
Conditions:
Hyperaldosteronism
Hypertension
Eligibility:
All Genders
18-75 years
Brief Summary
WHYSKI is a prospective within-patient observational clinical study designed to test the hypothesis that alterations of Na+, K+, water, and the lympho-angiogenetic transcription factor Tonicity Enhanc...
Detailed Description
Background. Given the key role of Na+ in the pathophysiology of HT, this study will test the hypothesis that in PA, which is the paradigm of salt-dependent hypertension, the skin, Na+, K+ and water co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06090617
Start Date
January 1 2021
End Date
January 1 2025
Last Update
March 19 2024
Active Locations (1)
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1
Azienda Ospedale Università di Padova
Padua, Italy, 35128