Decode the Environment Variation of Targeted Aldosterone Inducer and siLencer

NCT07748975 | Not Yet Recruiting

• 1 other identifier: NDejthida
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Aldosterone circulation profile

  The result, both qualitative and quantitative, from aldosterone synthesis to degradation and elimination via urine.

  12 months

• Aldoseterone synthesis profile

  Focus on both quantitative and qualitative evidence of aldosterone, CYP11B1, andand CYP11B2 protein

  12 months

Secondary Outcomes (1)

• Degradation Profile

  12 months

Study Arms (2)

Hypertensive Hyperaldosteronemia

EXPERIMENTAL

Diagnostic Test: Aldosterone circulation; Drug: Medication; Procedure: Operation

Hypertensive normoaldosteronemia

ACTIVE COMPARATOR

Diagnostic Test: Aldosterone circulation; Drug: Medication; Procedure: Operation

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

Hypertensive Hyperaldosteronemia; Hypertensive normoaldosteronemia

Medication DRUG

Medical treatment that interferes with free aldosterone levels and reports systolic blood pressure deviation

Hypertensive Hyperaldosteronemia; Hypertensive normoaldosteronemia

Operation PROCEDURE

The non-medical intervention includes MIS, Open surgery, and intravascular guide treatment aim to treat hypetension and lower aldosterone level.

Hypertensive Hyperaldosteronemia; Hypertensive normoaldosteronemia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Human birth in all sex chromosomes; evidence of systemic arterial hypertension, both treated and untreated.
• Evidence of living with owned systemic/arterial hypertension by one of the following;
• Quantitative: Blood pressure number higher than the normal range by each protocol in mmHg unit in any arm of study.
• Qualitative: Clarify whether both retrospective, observational, or intervention study of blood pressure, and clearly clarify the number of hypertension participants in the article.

You may not qualify if:

• Under 18 years old
• Specimens of studies not from humans or human specimens but not from an actual living hypertension patient, such as cell culture, in vitro synthesis from laboratory synthesis
• No evidence of hypertension in the main study
• Study of imaging confirms adrenal tumor in all types of histopathology results.

Sponsors & Collaborators

• DejthidaNathaphong: lead

Study Sites (1)

Investigation Center

Vadhana, Bangkok, 10110, Thailand

Location

MeSH Terms

Conditions

Hypertension

Interventions

Dosage Forms; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Nathaphong Dejthida, Medical Degree

CONTACT

+66819220662; bnnatto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 5, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)