- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Nathaphong Dejthida, Medical Degree
- Número de telefone: +66819220662
- E-mail: bnnatto@gmail.com
Locais de estudo
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Bangkok
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Vadhana, Bangkok, Tailândia, 10110
- Investigation Center
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Contato:
- Nathaphong Dejthida, Medical Degree
- Número de telefone: +66819220662
- E-mail: bnnatto@gmail.com
-
Contato:
- E-mail: bnnatto@gmail.com
-
Investigador principal:
- Nathaphong Dejthida, Medical Degree
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Hypertensive Hyperaldosteronemia
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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.
|
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Comparador Ativo: Hypertensive normoaldosteronemia
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Aldosterone circulation profile
Prazo: 12 months
|
The result, both qualitative and quantitative, from aldosterone synthesis to degradation and elimination via urine.
|
12 months
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Aldoseterone synthesis profile
Prazo: 12 months
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Focus on both quantitative and qualitative evidence of aldosterone, CYP11B1, andand CYP11B2 protein
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12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Degradation Profile
Prazo: 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
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12 months
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NDejthida
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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