Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion

NCT06955286 | Recruiting DMC

• 1 other identifier: 2025-040-01
• Study Type: observational
• Target: 521
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS). To assess the recovery time of postoperative adrenal insufficiency in patients. And to explore the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy.

Conditions

Primary Aldosteronism; Autonomous Cortisol Secretion; Adrenal Insufficiency

Keywords

Primary Aldosteronism; Autonomous Cortisol Secretion; Adrenal Insufficiency; ACTH stimulation test

Outcome Measures

Primary Outcomes (3)

• the Incidence rate of Adrenal Insufficiency After Surgery

  the Incidence rate of Adrenal Insufficiency After Surgery on the one day after surgery，which is defined as serum cortisol ≤ 390nmol/l 60 minutes after ACTH continuous infusion

  the one day after surgery

• the recovery time of postoperative Adrenal Insufficiency in patients

  the recovery time of postoperative Adrenal Insufficiency in patients. The patients will be completed ACTH stimulation test at 1 and 4 weeks after surgery. If serum cortisol \> 390nmol/l 60 minutes after ACTH continuous infusion，the patients will be considered as recovery

  the one day after surgery, or 1 and 4 weeks after surgery, or 3 or 6 months after surgery

• the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy

  the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy

  3 or 6 months after surgery

Study Arms (3)

Patients With Primary Aldosteronism

primary aldosteronism patients underwent surgical treatment and completed the ACTH stimulation test

Diagnostic Test: complete ACTH stimulation test the day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency

Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

primary aldosteronism patients concurrent with autonomous cortisol secretion underwent surgical treatment and completed the ACTH stimulation test

Diagnostic Test: complete ACTH stimulation test the day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency

Patients With With Autonomous Cortisol Secretion

patients with autonomous cortisol secretion underwent surgical treatment and completed the ACTH stimulation test

Diagnostic Test: complete ACTH stimulation test the day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency

Interventions

complete ACTH stimulation test the day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency DIAGNOSTIC_TEST

patients complete ACTH stimulation test on the one day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency

Patients With Primary Aldosteronism; Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion; Patients With With Autonomous Cortisol Secretion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion who underwent surgery and completed the ACTH stimulation test

You may not qualify if:

• Patients with typical clinical manifestations of Cushing's syndrome;
• Patients suspected of having bilateral cortisol over-secretion, such as PBMAH or PPNAD; ③ Patients with severe surgical complications, unstable postoperative condition (not due to cortical insufficiency), and difficulty completing the ACTH stimulation test;
• History of ACTH allergy;
• Patients requiring long-term hormone therapy for other diseases (such as autoimmune diseases);
• Severe liver and kidney dysfunction (ALT ≥ 3 times the upper limit of normal; patients undergoing dialysis or with an estimated glomerular filtration rate \< 30 ml/min/m2); ⑦ History of contralateral adrenal surgery; ⑧ Patients with poor compliance who are unable to complete the study.

Sponsors & Collaborators

• Qifu Li: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University, Chongqing, China

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (11)

• Libianto R, Russell GM, Stowasser M, Gwini SM, Nuttall P, Shen J, Young MJ, Fuller PJ, Yang J. Detecting primary aldosteronism in Australian primary care: a prospective study. Med J Aust. 2022 May 2;216(8):408-412. doi: 10.5694/mja2.51438. Epub 2022 Feb 25.

  PMID: 35218017 RESULT

• Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.

  PMID: 32327102 RESULT

• Nakajima Y, Yamada M, Taguchi R, Satoh T, Hashimoto K, Ozawa A, Shibusawa N, Okada S, Monden T, Mori M. Cardiovascular complications of patients with aldosteronism associated with autonomous cortisol secretion. J Clin Endocrinol Metab. 2011 Aug;96(8):2512-8. doi: 10.1210/jc.2010-2743. Epub 2011 May 18.

  PMID: 21593113 RESULT

• Naruse M, Katabami T, Shibata H, Sone M, Takahashi K, Tanabe A, Izawa S, Ichijo T, Otsuki M, Omura M, Ogawa Y, Oki Y, Kurihara I, Kobayashi H, Sakamoto R, Satoh F, Takeda Y, Tanaka T, Tamura K, Tsuiki M, Hashimoto S, Hasegawa T, Yoshimoto T, Yoneda T, Yamamoto K, Rakugi H, Wada N, Saiki A, Ohno Y, Haze T. Japan Endocrine Society clinical practice guideline for the diagnosis and management of primary aldosteronism 2021. Endocr J. 2022 Apr 28;69(4):327-359. doi: 10.1507/endocrj.EJ21-0508. Epub 2022 Apr 12.

  PMID: 35418526 RESULT

• Araujo-Castro M, Paja Fano M, Pla Peris B, Gonzalez Boillos M, Pascual-Corrales E, Garcia-Cano AM, Parra Ramirez P, Rojas-Marcos PM, Ruiz-Sanchez JG, Vicente A, Gomez-Hoyos E, Ferreira R, Garcia Sanz I, Recasens M, Barahona San Millan R, Picon Cesar MJ, Diaz Guardiola P, Perdomo C, Manjon L, Garcia-Centeno R, Percovich JC, Rebollo Roman A, Gracia Gimeno P, Robles Lazaro C, Morales M, Calatayud M, Collao SAF, Meneses D, Sampedro Nunez MA, Escudero Quesada V, Ribas EM, Sanmartin Sanchez A, Diaz CG, Lamas C, Guerrero-Vazquez R, Del Castillo Tous M, Serrano J, Michalopoulou T, Moya Mateo EM, Hanzu F. Autonomous cortisol secretion in patients with primary aldosteronism: prevalence and implications on cardiometabolic profile and on surgical outcomes. Endocr Connect. 2023 Aug 2;12(9):e230043. doi: 10.1530/EC-23-0043.

  PMID: 37410097 RESULT

• Fujimoto K, Honjo S, Tatsuoka H, Hamamoto Y, Kawasaki Y, Matsuoka A, Ikeda H, Wada Y, Sasano H, Koshiyama H. Primary aldosteronism associated with subclinical Cushing syndrome. J Endocrinol Invest. 2013 Sep;36(8):564-7. doi: 10.3275/8818. Epub 2013 Feb 4.

  PMID: 23385627 RESULT

• Katabami T, Matsuba R, Kobayashi H, Nakagawa T, Kurihara I, Ichijo T, Tsuiki M, Wada N, Ogawa Y, Sone M, Inagaki N, Yoshimoto T, Takahashi K, Yamamoto K, Izawa S, Kakutani M, Tanabe A, Naruse M. Primary aldosteronism with mild autonomous cortisol secretion increases renal complication risk. Eur J Endocrinol. 2022 Apr 25;186(6):645-655. doi: 10.1530/EJE-21-1131.

  PMID: 35380982 RESULT

• Wu WC, Peng KY, Lu JY, Chan CK, Wang CY, Tseng FY, Yang WS, Lin YH, Lin PC, Chen TC, Huang KH, Chueh JS, Wu VC. Cortisol-producing adenoma-related somatic mutations in unilateral primary aldosteronism with concurrent autonomous cortisol secretion: their prevalence and clinical characteristics. Eur J Endocrinol. 2022 Sep 14;187(4):519-530. doi: 10.1530/EJE-22-0286. Print 2022 Oct 1.

  PMID: 35900323 RESULT

• Liao YY, Song Y, Hu JB, Yang SM, Zheng Y, Li QF. [Clinical characteristics and prognosis of primary aldosteronism associated with subclinical Cushing syndrome]. Zhonghua Nei Ke Za Zhi. 2024 Apr 1;63(4):378-385. doi: 10.3760/cma.j.cn112138-20230830-00100. Chinese.

  PMID: 38561283 RESULT

• DeLozier OM, Dream SY, Findling JW, Carroll TB, Evans DB, Wang TS. Selective Glucocorticoid Replacement Following Unilateral Adrenalectomy for Hypercortisolism and Primary Aldosteronism. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e538-e547. doi: 10.1210/clinem/dgab698.

  PMID: 34558612 RESULT

• Gerards J, Heinrich DA, Adolf C, Meisinger C, Rathmann W, Sturm L, Nirschl N, Bidlingmaier M, Beuschlein F, Thorand B, Peters A, Reincke M, Roden M, Quinkler M. Impaired Glucose Metabolism in Primary Aldosteronism Is Associated With Cortisol Cosecretion. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3192-3202. doi: 10.1210/jc.2019-00299.

  PMID: 30865224 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Hyperaldosteronism; Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Li Qifu, PhD

CONTACT

+86-023-89011552; liqifu@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)