- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07748975
Decode the Environment Variation of Targeted Aldosterone Inducer and siLencer (DETAIL)
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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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 Axin-CK1-GSK3-APC-Beta-catenin complex
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nathaphong Dejthida, Medical Degree
- Telefonní číslo: +66819220662
- E-mail: bnnatto@gmail.com
Studijní místa
-
-
Bangkok
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Vadhana, Bangkok, Thajsko, 10110
- Investigation Center
-
Kontakt:
- Nathaphong Dejthida, Medical Degree
- Telefonní číslo: +66819220662
- E-mail: bnnatto@gmail.com
-
Kontakt:
- E-mail: bnnatto@gmail.com
-
Vrchní vyšetřovatel:
- Nathaphong Dejthida, Medical Degree
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Hypertensive Hyperaldosteronemia
|
Evidence of synthesis of aldosterone and/or degradation of inactive forms of aldosterone, which focuses on
Medical treatment that interferes with free aldosterone levels and reports systolic blood pressure deviation The non-medical intervention includes MIS, Open surgery, and intravascular guide treatment aim to treat hypetension and lower aldosterone level. |
|
Aktivní komparátor: Hypertensive normoaldosteronemia
|
Evidence of synthesis of aldosterone and/or degradation of inactive forms of aldosterone, which focuses on
Medical treatment that interferes with free aldosterone levels and reports systolic blood pressure deviation The non-medical intervention includes MIS, Open surgery, and intravascular guide treatment aim to treat hypetension and lower aldosterone level. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Aldosterone circulation profile
Časové okno: 12 months
|
The result, both qualitative and quantitative, from aldosterone synthesis to degradation and elimination via urine. |
12 months
|
|
Aldoseterone synthesis profile
Časové okno: 12 months
|
Focus on both quantitative and qualitative evidence of aldosterone, CYP11B1, andand CYP11B2 protein |
12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Degradation Profile
Časové okno: 12 months
|
Focus on the ratio of degradation activity of the inactive form of aldosterone and the inhibitory competitor inhibits the cell product from the aldosterone-mineralocorticoid receptor. Axin-CK1-GSK3-APC complex profile is indicated |
12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NDejthida
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The recruitment is published data already
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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