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shouyue SUN, MD

Epidemiologic studies have revealed a tremendous increase in the prevalence of adrenal associated disease and related mortality worldwide. In order to meet all the therapeutic challenges in adrenal disease in China, CASE was founded in 2020. The objective of CASE is to launch an adrenal disease management model based on the Internet health information platform which allows the application and evaluation of adrenal disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of adrenal disease, diagnosis, and treatment.

In order to meet all the challenges in the diagnosis and treatment of adrenal diseases in China, CASE was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CASE is committed to creating an online and offline integrated solution for adrenal disease, and for the entire spectrum of adrenal disease, to achieve a more convenient and precise model of care for patients, aiming to establish a platform with diagnosis and treatment of adrenal disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.

China Adrenal Disease Registry

China Adrenal Disease Registry Study

The symptom checklist-90 will be used to evaluate the changes of participants' psychological state through study completion from 10 aspects, including somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, terror, paranoia, psychotic and others.

Shanghai Jiao Tong University School of Medicine

Director, Head of Endocrinology, Principal Investigator, Clinical Professor

Heart and Blood Diseases

Immune System Diseases

Hypertension

Essential Hypertension

Hypersensitivity

Vascular Diseases

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)

Presumed diagnosis of bilateral PA, defined as above but without evidence of lateralized aldosterone excess.

Primary (essential) Hypertension (PH): conclusively ascertained high blood pressure and exclusion of secondary hypertension

comprising patients submitted to surgery but free of hypertension

Skin biopsies were obtained in all recruited patients.

Skin Biopsy

Video-laparoscopic adrenalectomy in those with unilateral PA. (PA group 1)

Video-laparoscopic adrenalectomy

Gian Paolo Rossi, Prof.

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.

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 content is altered and these alterations are corrected by surgical cure of PA with video-laparoscopic adrenalectomy. The investigators will use skin biopsies to directly examine the content of Na+, K+, water, and the lympho-angiogenetic transcription factor Tonicity Enhancing Binding Protein (TonEBP) mRNA in the skin, an important reservoir of body Na+, in primary aldosteronism (PA), the prototype of salt-dependent hypertension.

Methods. The investigators will measure Na+, K+, and water content (by chemical-physical methods) and TonEBP mRNA copy number (by droplet digital PCR) in skin biopsies from a sex-mixed cohort of consecutive consenting patients with unilateral PA treated with a mineralocorticoid receptor antagonist (MRA), before surgery, at doses that correct hypokalemia and HT in order to refer them for surgery with normokalemia and controlled high blood pressure, as per protocol at our institution. The participants will be reassessed in an identical way again after surgical cure.

The investigators expect the dry weight (DW) of the skin specimen obtained at surgery to be significantly higher than at follow-up and to correlate positively with skin Na+, K+, and water content. Hence, if these predictions will be verified, the skin cations and water content will need to be DW-adjusted in order to provide meaningful comparisons across specimen obtained at different time points. The investigators expect the TonEBP mRNA copy number to be markedly overexpressed compared to healthy subjects.

The WHYSKI study will provide solid knowledge of the skin Na+, K+ and water content in patients with arterial salt-dependent hypertension due to PA, PH, and on the effect of cure of the hyperaldosteronism on these variables. The investigators also expect to gather novel knowledge on the molecular and cellular mechanisms involved in the regulation of the content on Na+, K+ and water in a compartment as the skin interstitium that has been largely neglected thus far.

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

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

IPD available on reasonable request but if consistent with the ongoing privacy legislation.

With validated chemical physical methods, we will measure the Na+, K+ and water content in the skin of patients with primary aldosteronism (PA, PA Group), primary (essential) hypertension HT patients (PH Group) and in normotensive patients (Control Group). The skin biopsy will be performed during adrenalectomy in consecutive patients with confirmed unilateral PA (PA Group) and in parallel in the same anatomical region in the PH group and in the Control Group, during surgery for benign diseases.

To verify if the cure of PA improves Na+, K+ and water skin clearance in the PA Group the skin biopsy obtained during adrenalectomy will be within-patient compared to that obtained one month after adrenalectomy (PA Group 1). In PA patients found not to have unilateral PA (PA Group 2), the biopsy will be obtained after one month of target medical treatment with canrenone, a mineralocorticoid receptor antagonist.

While the measurement of skin Na+, K+ and water is the main study outcome, an additional important goal will be to determine the molecular mechanisms driven by "skin sodium storage" that underlie the crosstalk between skin cells, macrophages and lymphatic vessels in the interstitium of the patient with PA (PA group 1) and essential hypertensive patients (EH Group) compared with the normotensive patient (Control Group). To this end we will explore the mRNA content of Tonicity-Enhancing Binding Protein TonEBP (also known as NFAT5), a transcription factor known to activate neo-lymphoangiogenesis, using molecular biology techniques.

University Hospital Padova

Full Professor of Internal Medicine, MD, FAHA, FACC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
China Adrenal Disease Registry	NCT04890444	Cushing Syndrom... Aldosteronism Hypoadrenalism Congenital Adre... Adrenal Adenoma Adrenal Inciden... Adrenal Carcino... Pheochromocytom...		16 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Water and Electrolytes Content in HYpertension (WHYSKI) in the SKIn	NCT06090617	Hyperaldosteron... Hypertension Aldosterone-pro... Aldosteronism Aldosterone Dis... Essential Hyper... Bilateral Adren... Conn Adenoma	Skin Biopsy Video-laparosco...	18 Years - 75 Years	University Hospital Padova
China Adrenal Disease Registry	NCT04890444	Cushing Syndrom... Aldosteronism Hypoadrenalism Congenital Adre... Adrenal Adenoma Adrenal Inciden... Adrenal Carcino... Pheochromocytom...		16 Years - 75 Years	Shanghai Jiao Tong University School of Medicine

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