- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nathaphong Dejthida, Medical Degree
- Numer telefonu: +66819220662
- E-mail: bnnatto@gmail.com
Lokalizacje studiów
-
-
Bangkok
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Vadhana, Bangkok, Tajlandia, 10110
- Investigation Center
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Kontakt:
- Nathaphong Dejthida, Medical Degree
- Numer telefonu: +66819220662
- E-mail: bnnatto@gmail.com
-
Kontakt:
- E-mail: bnnatto@gmail.com
-
Główny śledczy:
- Nathaphong Dejthida, Medical Degree
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Ekranizacja
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Aldosterone circulation profile
Ramy czasowe: 12 months
|
The result, both qualitative and quantitative, from aldosterone synthesis to degradation and elimination via urine. |
12 months
|
|
Aldoseterone synthesis profile
Ramy czasowe: 12 months
|
Focus on both quantitative and qualitative evidence of aldosterone, CYP11B1, andand CYP11B2 protein |
12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Degradation Profile
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NDejthida
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
The recruitment is published data already
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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