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L'essai clinique NCT06228677 pour Hypertension résistante, Hypertension secondaire, Secondary Hypertension to Endocrine Disorders, Hyperaldostéronisme Primaire est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization

En recrutement
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L'étude clinique NCT06228677 est un essai observationnel pour Hypertension résistante, Hypertension secondaire, Secondary Hypertension to Endocrine Disorders, Hyperaldostéronisme Primaire. Son statut actuel est : en recrutement. L'étude a débuté le 18 septembre 2023 et vise à recruter 196 participants. Dirigé par First Affiliated Hospital of Chengdu Medical College, l'essai devrait être terminé d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 29 janvier 2024.
Résumé succinct
To explore the relationship between perioperative blood pressure and catecholamine concentrations in adrenal venous blood and peripheral venous blood in hypertensive patients with primary aldosteronism (PA) who underwent percutaneous selective adrenal artery embolization (SAAE). In order to elucidate the related phenomena and possible mechanisms of blood pressure fluctuations caused by SAAE treatment in hypertensive patients with PA.
Description détaillée
Percutaneous selective adrenal artery embolization (SAAE) is a minimally invasive interventional procedure that allows for necrosis of diseased adrenal glands by selectively embolizing the adrenal arteries supplying the lesion using an embolic agent to block the overproduction of aldosterone, and has been used as a treatment for PA as a minimally invasive alternative. However, it is of concern that in our team's SAAE practice, we have found that some patients with PA experience a dramatic increase in blood pressure during surgery, even exceeding 220/130 mmHg, yet some patients do not experience significant fluctuations in blood pressure. The perioperative risk is undoubtedly significantly increased for patients with high blood pressure fluctuations. What are the reasons for this discrepancy phenomenon? Therefore, the present study was designed to synchronize adrenal vein blood collection in PA hypertensive patients undergoing SAAE, and to compare the perioperative adrenal vein blood and peripheral venous blood catecholamine concentrations, with a view to discovering the patterns and possible causes of blood pressure fluctuations, hormone level changes, and other phenotypic changes, and elucidating the possible mechanisms of blood pressure fluctuations triggered by SAAE treatment of PA hypertension, in order to provide an evidence-based basis for minimally invasive interventional therapy for PA.
Titre officiel

Comparison of Catecholamine Concentrations in Adrenal Venous Blood and Peripheral Venous Blood During Percutaneous Selective Adrenal Artery Embolization in Hypertensive Patients With Primary Aldosteronism: A Prospective Cohort Study

Conditions
Hypertension résistanteHypertension secondaireSecondary Hypertension to Endocrine DisordersHyperaldostéronisme Primaire
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • CCC-SAAE
Numéro NCT
Date de début (réel)
2023-09-18
Dernière mise à jour publiée
2024-01-29
Date de fin (estimée)
2026-12-31
Inscription (estimée)
196
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
Primary Aldosteronism
Selective Adrenal Artery Embolization
catecholamine concentration
Adrenal Venous Blood
Blood Pressure Variability
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Adrenal Venous Sampling Group
Adrenal veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Selective Adrenal Artery Embolization
Percutaneous selective adrenal artery embolization in patients with primary aldosteronism
Peripheral Venous Sampling Group
Peripheral veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Selective Adrenal Artery Embolization
Percutaneous selective adrenal artery embolization in patients with primary aldosteronism
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Invasive blood pressure
Auxiliary check
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
24-hour dynamic blood pressure
Auxiliary check
Selective adrenal artery embolization before 24 hours, after 24 hours
Plasma Norepinephrine
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Plasma Adrenaline
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Plasma Dopamin
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Plasma Renin
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Plasma Aldosterone
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Serum sodium
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Serum potassium
Biochemical indicators
Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Age ≥18 years with no gender restrictions.
  2. Adherence to the "Primary Aldosteronism" Diagnosis and Treatment Guidelines, confirmed diagnosis of primary aldosteronism following rigorous drug washout, and identification as either aldosteronoma or idiopathic aldosteronism via adrenal vein blood sampling.
  3. Blood pressure metrics that satisfy any of the subsequent conditions: a) Clinic-recorded blood pressure ≥140/90mmHg; b) 24-hour ambulatory blood pressure monitoring results displaying average blood pressure >130/80 mmHg or daytime readings >135/85 mmHg.
  4. Adrenal CT scan revealing adrenal hyperplasia, nodular formations, or no significant morphological deviations.
  5. Hypertension history surpassing a duration of 6 months.
  6. Prior to screening, patients or their lawful guardians must provide a signed informed consent, sanctioned by the ethics committee.

  1. Patients diagnosed with primary hypertension or secondary hypertension attributed to other etiologies.
  2. Female participants who are presently pregnant, lactating, or with intentions to conceive within the forthcoming year.
  3. Presence of significant systemic diseases, with particular attention to hepatic and renal dysfunction.
  4. Pronounced allergic reaction to contrast agents.
  5. Any other serious systemic diseases with a life expectancy of less than 12 months.
  6. Participants concurrently enrolled or expressing interest to participate in other clinical trials, the outcomes of which could potentially influence the results of the current study.
  7. The researcher's discretion deems the subject inappropriate for inclusion in the study for any given reason.
First Affiliated Hospital of Chengdu Medical College logoFirst Affiliated Hospital of Chengdu Medical College
Contact central de l'essai
Contact: Peijian Wang, PhD, 028-83016145, [email protected]
Contact: Sen Liu, MD, 028-83016150, [email protected]
1 Centres de l'essai dans 1 pays

Sichuan

The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, 610500, China
Peijian Wang, PhD, Contact, 028-83016145, [email protected]
En recrutement