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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
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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 PrimairePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:- Stavropoulos K, Imprialos KP, Patoulias D, Katsimardou A, Doumas M. Impact of Primary Aldosteronism in Resistant Hypertension. Curr Hypertens Rep. 2022 Aug;24(8):285-294. doi: 10.1007/s11906-022-01190-9. Epub 2022 Apr 21.
- Huang WC, Lin YH, Wu VC, Chen CH, Siddique S, Chia YC, Tay JC, Sogunuru G, Cheng HM, Kario K. Who should be screened for primary aldosteronism? A comprehensive review of current evidence. J Clin Hypertens (Greenwich). 2022 Sep;24(9):1194-1203. doi: 10.1111/jch.14558.
- Meng Z, Dai Z, Huang K, Xu C, Zhang YG, Zheng H, Liu TZ. Long-Term Mortality for Patients of Primary Aldosteronism Compared With Essential Hypertension: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2020 Mar 10;11:121. doi: 10.3389/fendo.2020.00121. eCollection 2020.
- Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9.
- Funder JW, Carey RM. Primary Aldosteronism: Where Are We Now? Where to From Here? Hypertension. 2022 Apr;79(4):726-735. doi: 10.1161/HYPERTENSIONAHA.121.18761. Epub 2022 Jan 24.
- Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
- Lu YC, Liu KL, Wu VC, Wang SM, Lin YH, Chueh SJ, Wu KD, Su YR, Huang KH; TAIPAI Study Group. Unilateral adrenalectomy in bilateral adrenal hyperplasia with primary aldosteronism. J Formos Med Assoc. 2023 May;122(5):393-399. doi: 10.1016/j.jfma.2022.12.015. Epub 2023 Feb 20.
- Tezuka Y, Turcu AF. Real-World Effectiveness of Mineralocorticoid Receptor Antagonists in Primary Aldosteronism. Front Endocrinol (Lausanne). 2021 Mar 26;12:625457. doi: 10.3389/fendo.2021.625457. eCollection 2021.
- Fowler AM, Burda JF, Kim SK. Adrenal artery embolization: anatomy, indications, and technical considerations. AJR Am J Roentgenol. 2013 Jul;201(1):190-201. doi: 10.2214/AJR.12.9507.
- Hokotate H, Inoue H, Baba Y, Tsuchimochi S, Nakajo M. Aldosteronomas: experience with superselective adrenal arterial embolization in 33 cases. Radiology. 2003 May;227(2):401-6. doi: 10.1148/radiol.2272011798. Epub 2003 Apr 3.
- Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.
- Zhou Y, Liu Q, Wang X, Wan J, Liu S, Luo T, He P, Hou J, Pu J, Wang D, Liang D, Yang Y, Wang P. Adrenal Ablation Versus Mineralocorticoid Receptor Antagonism for the Treatment of Primary Aldosteronism: A Single-Center Prospective Cohort Study. Am J Hypertens. 2022 Dec 8;35(12):1014-1023. doi: 10.1093/ajh/hpac105.
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
Selective Adrenal Artery Embolization
catecholamine concentration
Adrenal Venous Blood
Blood Pressure Variability
Bras / Interventions
| Groupe de participants/Bras | Intervention/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'évaluation | Description de critères | Période |
|---|---|---|
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
- Age ≥18 years with no gender restrictions.
- 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.
- 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.
- Adrenal CT scan revealing adrenal hyperplasia, nodular formations, or no significant morphological deviations.
- Hypertension history surpassing a duration of 6 months.
- Prior to screening, patients or their lawful guardians must provide a signed informed consent, sanctioned by the ethics committee.
- Patients diagnosed with primary hypertension or secondary hypertension attributed to other etiologies.
- Female participants who are presently pregnant, lactating, or with intentions to conceive within the forthcoming year.
- Presence of significant systemic diseases, with particular attention to hepatic and renal dysfunction.
- Pronounced allergic reaction to contrast agents.
- Any other serious systemic diseases with a life expectancy of less than 12 months.
- 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.
- The researcher's discretion deems the subject inappropriate for inclusion in the study for any given reason.
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