System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Observational Recruiting

NCT06090617 on ClinicalTrials.gov

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

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

  • Sponsor: Azienda Ospedaliera di Padova
  • Enrollment: 35 (Estimated)
  • Study start: 2021-01-01 (Actual)
  • Primary completion: 2024-04-01 (Estimated)
  • Study completion: 2025-01-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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 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.

Conditions

  • Hyperaldosteronism
  • Hypertension
  • Aldosterone-producing Adenoma
  • Aldosteronism
  • Aldosterone Disorder
  • Essential Hypertension
  • Bilateral Adrenal Hyperplasia
  • Conn Adenoma

Intervention / Treatment

  • Procedure: Skin Biopsy
  • Procedure: Video-laparoscopic adrenalectomy

Primary Outcome Measures

  • 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). (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.

Countries

Italy

Locations and Investigators