HyperaldosteronismWHYSKINCT06090617
Water and Electrolytes Content in HYpertension (WHYSKI) in the SKIn
An observational study of Hyperaldosteronism and Hypertension, run by University Hospital Padova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperaldosteronism, Hypertension, Aldosterone-producing Adenoma
- What is being tested?
- Skin Biopsy and Video-laparoscopic adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to either the Endocrine Surgery unit, the Specialized Center for Blood Pressure Disorders of Regione Veneto of the Azienda Ospedale-Università di Padova, or other surgery departments of the same institution were recruited.
Who may be able to join
- 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
Show all 20Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedale Università di Padova
Padova, 35128
Gian Paolo Rossi, Prof., 0039 0498212279, segreteria.ipertensioneaopd@aopd.veneto.it
About this study
Official title: The Water and Electrolytes Content in Salt-dependent Human HYpertension (WHYSKI) in the SKIn Before and After Surgical Cure of Primary Aldosteronism
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.
Read the 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 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.
- Conditions
- Hyperaldosteronism, Hypertension, Aldosterone-producing Adenoma, Aldosteronism, Aldosterone Disorder, Essential Hypertension
- Being tested
- Skin Biopsy, Video-laparoscopic adrenalectomy
- Keywords
- Salt-dependent Hypertension, Primary Aldosteronism, Salt-sensitive, Blood Pressure, TonEBP, Tonicity Enhancing Binding Protein, RAAS, Renin Angiotensin Aldosterone System, BP, GAGs, Glycosaminoglycans
- Medical subject headings
- Hyperaldosteronism, Hypertension, Adrenocortical Adenoma, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin BiopsyProcedure or surgery
Skin biopsies were obtained in all recruited patients.
Video-laparoscopic adrenalectomyProcedure or surgery
Video-laparoscopic adrenalectomy in those with unilateral PA. (PA group 1)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Skin Biopsy; Procedure: Video-laparoscopic adrenalectomy | |
| PA group 2 | Presumed diagnosis of bilateral PA, defined as above but without evidence of lateralized aldosterone excess. Receives: Procedure: Skin Biopsy | |
| PH Group | Primary (essential) Hypertension (PH): conclusively ascertained high blood pressure and exclusion of secondary hypertension Receives: Procedure: Skin Biopsy | |
| Non Hypertensive Control Group | comprising patients submitted to surgery but free of hypertension Receives: Procedure: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: Baseline (Surgery), Month 1 after Surgery (for PA Group 1 only)
Secondary outcomes (1)
mRNA content of Tonicity-Enhancing Binding Protein TonEBP (also known as NFAT5)
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.
Measured: Baseline (Surgery), Month 1 after Surgery (for PA Group 1 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090617
- Sponsor's protocol ID
- AOP1615
- Acronym
- WHYSKI
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD available on reasonable request but if consistent with the ongoing privacy legislation.
Publications
Wiig H, Luft FC, Titze JM. The interstitium conducts extrarenal storage of sodium and represents a third compartment essential for extracellular volume and blood pressure homeostasis. Acta Physiol (Oxf). 2018 Mar;222(3). doi: 10.1111/apha.13006. Epub 2017 Dec 20.
PubMed 29193764Rossier BC, Bochud M, Devuyst O. The Hypertension Pandemic: An Evolutionary Perspective. Physiology (Bethesda). 2017 Mar;32(2):112-125. doi: 10.1152/physiol.00026.2016.
PubMed 28202622Rossi GP, Bisogni V, Bacca AV, Belfiore A, Cesari M, Concistre A, Del Pinto R, Fabris B, Fallo F, Fava C, Ferri C, Giacchetti G, Grassi G, Letizia C, Maccario M, Mallamaci F, Maiolino G, Manfellotto D, Minuz P, Monticone S, Morganti A, Muiesan ML, Mulatero P, Negro A, Parati G, Pengo MF, Petramala L, Pizzolo F, Rizzoni D, Rossitto G, Veglio F, Seccia TM. The 2020 Italian Society of Arterial Hypertension (SIIA) practical guidelines for the management of primary aldosteronism. Int J Cardiol Hypertens. 2020 Apr 15;5:100029. doi: 10.1016/j.ijchy.2020.100029. eCollection 2020 Jun.
PubMed 33447758Elijovich F, Weinberger MH, Anderson CA, Appel LJ, Bursztyn M, Cook NR, Dart RA, Newton-Cheh CH, Sacks FM, Laffer CL; American Heart Association Professional and Public Education Committee of the Council on Hypertension; Council on Functional Genomics and Translational Biology; and Stroke Council. Salt Sensitivity of Blood Pressure: A Scientific Statement From the American Heart Association. Hypertension. 2016 Sep;68(3):e7-e46. doi: 10.1161/HYP.0000000000000047. Epub 2016 Jul 21. No abstract available.
PubMed 27443572Torresan F, Rossi FB, Caputo I, Zanin S, Caroccia B, Mattarei A, Paccagnella M, Kohlscheen E, Seccia TM, Iacobone M, Rossi GP. Water and Electrolyte Content in Hypertension in the Skin (WHYSKI) in Primary Aldosteronism. Hypertension. 2024 Dec;81(12):2468-2478. doi: 10.1161/HYPERTENSIONAHA.124.23700. Epub 2024 Oct 2.
PubMed 39355924Torresan F, Rossi FB, Zanin S, Caputo I, Caroccia B, Iacobone M, Rossi GP. Water and Electrolyte Content in Salt-Dependent HYpertension in the SKIn (WHYSKI): Effect of Surgical Cure of Primary Aldosteronism. High Blood Press Cardiovasc Prev. 2024 Jan;31(1):15-21. doi: 10.1007/s40292-023-00614-0. Epub 2023 Dec 21.
PubMed 38123759
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Water and Electrolytes Content in Salt-dependent Human HYpertension (WHYSKI) in the SKIn Before and After Surgical Cure of Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT06090617
- Acronym / sponsor ID
- WHYSKI / AOP1615
- Conditions
- Hyperaldosteronism, Hypertension, Aldosterone-producing Adenoma, Aldosteronism, Aldosterone Disorder, Essential Hypertension
- Keywords
- Salt-dependent Hypertension, Primary Aldosteronism, Salt-sensitive, Blood Pressure, TonEBP, Tonicity Enhancing Binding Protein, RAAS, Renin Angiotensin Aldosterone System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PA group 1 | – | Procedure: Skin Biopsy, Procedure: Video-laparoscopic adrenalectomyconclusive 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 | – | Procedure: Skin BiopsyPresumed diagnosis of bilateral PA, defined as above but without evidence of lateralized aldosterone excess. |
| PH Group | – | Procedure: Skin BiopsyPrimary (essential) Hypertension (PH): conclusively ascertained high blood pressure and exclusion of secondary hypertension |
| Non Hypertensive Control Group | – | Procedure: Skin Biopsycomprising patients submitted to surgery but free of hypertension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to either the Endocrine Surgery unit, the Specialized Center for Blood Pressure Disorders of Regione Veneto of the Azienda Ospedale-Università di Padova, or other surgery departments of the same institution were recruited.
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin BiopsySkin biopsies were obtained in all recruited patients. | Procedure or surgery | Non Hypertensive Control Group, PA group 1, PA group 2, PH Group |
| Video-laparoscopic adrenalectomyVideo-laparoscopic adrenalectomy in those with unilateral PA. (PA group 1) | Procedure or surgery | PA group 1 |
Primary outcome
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).
Time frame: Baseline (Surgery), Month 1 after Surgery (for PA Group 1 only)
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.
1 secondary outcome
mRNA content of Tonicity-Enhancing Binding Protein TonEBP (also known as NFAT5)
Time frame: Baseline (Surgery), Month 1 after Surgery (for PA Group 1 only)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 29193764Wiig H, Luft FC, Titze JM. The interstitium conducts extrarenal storage of sodium and represents a third compartment essential for extracellular volume and blood pressure homeostasis. Acta Physiol (Oxf). 2018 Mar;222(3). doi: 10.1111/apha.13006. Epub 2017 Dec 20.
- Background: PubMed 28202622Rossier BC, Bochud M, Devuyst O. The Hypertension Pandemic: An Evolutionary Perspective. Physiology (Bethesda). 2017 Mar;32(2):112-125. doi: 10.1152/physiol.00026.2016.
- Background: PubMed 33447758Rossi GP, Bisogni V, Bacca AV, Belfiore A, Cesari M, Concistre A, Del Pinto R, Fabris B, Fallo F, Fava C, Ferri C, Giacchetti G, Grassi G, Letizia C, Maccario M, Mallamaci F, Maiolino G, Manfellotto D, Minuz P, Monticone S, Morganti A, Muiesan ML, Mulatero P, Negro A, Parati G, Pengo MF, Petramala L, Pizzolo F, Rizzoni D, Rossitto G, Veglio F, Seccia TM. The 2020 Italian Society of Arterial Hypertension (SIIA) practical guidelines for the management of primary aldosteronism. Int J Cardiol Hypertens. 2020 Apr 15;5:100029. doi: 10.1016/j.ijchy.2020.100029. eCollection 2020 Jun.
- Background: PubMed 27443572Elijovich F, Weinberger MH, Anderson CA, Appel LJ, Bursztyn M, Cook NR, Dart RA, Newton-Cheh CH, Sacks FM, Laffer CL; American Heart Association Professional and Public Education Committee of the Council on Hypertension; Council on Functional Genomics and Translational Biology; and Stroke Council. Salt Sensitivity of Blood Pressure: A Scientific Statement From the American Heart Association. Hypertension. 2016 Sep;68(3):e7-e46. doi: 10.1161/HYP.0000000000000047. Epub 2016 Jul 21. No abstract available.
- Derived from this study: PubMed 39355924Torresan F, Rossi FB, Caputo I, Zanin S, Caroccia B, Mattarei A, Paccagnella M, Kohlscheen E, Seccia TM, Iacobone M, Rossi GP. Water and Electrolyte Content in Hypertension in the Skin (WHYSKI) in Primary Aldosteronism. Hypertension. 2024 Dec;81(12):2468-2478. doi: 10.1161/HYPERTENSIONAHA.124.23700. Epub 2024 Oct 2.
- Derived from this study: PubMed 38123759Torresan F, Rossi FB, Zanin S, Caputo I, Caroccia B, Iacobone M, Rossi GP. Water and Electrolyte Content in Salt-Dependent HYpertension in the SKIn (WHYSKI): Effect of Surgical Cure of Primary Aldosteronism. High Blood Press Cardiovasc Prev. 2024 Jan;31(1):15-21. doi: 10.1007/s40292-023-00614-0. Epub 2023 Dec 21.
- Individual participant dataSharing planned: Yes. IPD available on reasonable request but if consistent with the ongoing privacy legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azienda Ospedale Università di Padova
Padova, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperaldosteronism and Hypertension, run by University Hospital Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Baseline (Surgery), Month 1 after Surgery (for PA Group 1 only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090617, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.