The Water and Electrolytes Content in Salt-dependent Human HYpertension (WHYSKI) in the SKIn Before and After Surgical Cure of Primary Aldosteronism

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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 Enhancing Binding Protein (TonEBP) mRNA take place in the interstitium of the skin compartment of patients with arterial hypertension due to primary aldosteronism in whom hypertension can be surgically cured.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
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∙ 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).

Locations
Other Locations
Italy
Azienda Ospedale Università di Padova
RECRUITING
Padua
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 35
Treatments
PA group 1
conclusive diagnosis of unilateral PA by the four corners criteria:~1. Biochemical evidence of PA~2. Lateralization of aldosterone secretion at adrenal venous sampling.~3. Correction of biochemical values and fall of blood pressure after adrenalectomy.~4. Immunohistochemical demonstration of CYP11B2 positive nodule(s)
PA group 2
Presumed diagnosis of bilateral PA, defined as above but without evidence of lateralized aldosterone excess.
PH Group
Primary (essential) Hypertension (PH): conclusively ascertained high blood pressure and exclusion of secondary hypertension
Non Hypertensive Control Group
comprising patients submitted to surgery but free of hypertension
Sponsors
Leads: University Hospital Padova

This content was sourced from clinicaltrials.gov