Decode the Environment Variation of Targeted Aldosterone Inducer and siLencer

Sponsor
DejthidaNathaphong
Study ID
NCT07748975
Status
Not Yet Recruiting

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Conditions

  • Aldosterone Synthase
  • Aldosteronemia
  • Beta-catenin
  • CYP11B1
  • CYP11B2
  • Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Aldosterone circulation — DIAGNOSTIC_TEST
    Evidence of synthesis of aldosterone and/or degradation of inactive forms of aldosterone, which focuses on * CYP450 Family 11 Subfamily B * Aldosterone protein * Beta-catenin * Axin-CK1-GSK3-APC complex
  • Medication — DRUG
    Medical treatment that interferes with free aldosterone levels and reports systolic blood pressure deviation
  • Operation — PROCEDURE
    The non-medical intervention includes MIS, Open surgery, and intravascular guide treatment aim to treat hypetension and lower aldosterone level.

Study Details

Clinical outcome to identify and analyze the epigenetic, phenotypic, protein variation, metabolites of CYP450 Family 11 Subfamily B, both 1 and 2, human-associated aldosterone protein release, and signaling inhibitory pathways post-aldosterone-mineralocorticoid interaction. We will include clinical studies (RCTs, cohort, case-control/series/report) from fresh human specimens. We will exclude animal studies, studies generated from cell culture, and aldosterone synthesis. To systematically review and synthesize the literature on the main 2 questions Question 1: Which environment induces CYP11B1 or CYP11B2 activation causing hyperaldosteronemia in hypertension patients? Question 2: Which intracellular signal silences aldosterone-MR activity? For Individual Participant Data Meta-analysis, data will be extracted from final analysis articles from the framework of the data selection process only; the effect measurement and multi-variable model meta-analysis will be performed. Primary Objective1: to identify CYP450 Family 11 Subfamily B and Aldosterone in hypertension patients following; By structure ● Evidence confirms Epigenetic profile of CYP450 Family 11 Subfamily B, Aldosterone, Signal in hypertension patients, both random and treated from any DNA sequencing method Protein synthesis evidence of aldosterone protein induces hypertension from Western blot or LC-MS By function Metabolomic profile: the substrate or product refers to aldosterone interaction causing end-organ cell line dysfunction or impaired structure. Inhibitory signaling profiling of hypertension patients compared to non-hypertension patients, which negatively feedback to CYP450 Family 11 Subfamily B or Aldosterone Secondary Objective 2: Sub-group analysis effect measurement following; * Proposed mechanisms, biological markers, or pathways that contribute to failure to regulate aldosteronemia * Treatment-related permanent normotensive post-hyperaldosteronemia. Primary Objective 2: Identify possible intracellular signal inhibit aldosterone action * Analyze possible mechanisms of signal that are silent aldosterone-MR activity * Differentiation of free aldosterone and attached aldosterone Secondary Objective 2: ● Sensitivity and specificity of outcomes of hypertension patients who underwent estimate substrate associated aldosterone circulation Plasma CYP450 Family 11 Subfamily B Urine CYP450 Family 11 Subfamily B Plasma Aldosterone (active form) Plasma Aldosterone (metabolite form) Urine Aldosterone

Key Dates

First listed
Aug 6, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Feb 10, 2027
Completion
Feb 5, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Hypertensive Hyperaldosteronemia
  • Active Comparator: Hypertensive normoaldosteronemia

Primary Outcome Measure

Aldosterone circulation profile [ Time Frame: 12 months ]

Central Contacts

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