CClinicalTrials.gg
Sign In
RecruitingNCT06955286Updated May 1, 2026

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

An observational study in Primary Aldosteronism, Autonomous Cortisol Secretion and Adrenal Insufficiency, sponsored by Qifu Li. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Qifu Li · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
521
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This study is a prospective, single-center research. Primary aldosteronism patients concurrent with or without autonomous cortisol secretion who underwent adrenalectomy and completed the adrenocorticotropic hormone (ACTH) stimulation test will be included. 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..

02

Conditions studied

  • Primary Aldosteronism
  • Autonomous Cortisol Secretion
  • Adrenal Insufficiency

Keywords

  • Primary Aldosteronism
  • Autonomous Cortisol Secretion
  • Adrenal Insufficiency
  • ACTH stimulation test
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Eligibility criteria

  • A confirmed diagnosis of primary aldosteronism or autonomous cortisol secretion;

    ② Completion of unilateral adrenal surgery;

    ③ Voluntary participation and obtaining informed consent. (2) Exclusion criteria

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
521 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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

    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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: the one day after surgery

  2. 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

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

  3. 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

    Time frame: 3 or 6 months after surgery

06

Study locations

1 of 1 sites recruiting
  • the First Affiliated Hospital of Chongqing Medical University, Chongqing, China
    Chongqing, Chongqing Municipality 400016, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 35218017 ↗
  • 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. PubMed 32327102 ↗
  • 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. PubMed 21593113 ↗
  • 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. PubMed 35418526 ↗
  • 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. PubMed 37410097 ↗
  • 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. PubMed 23385627 ↗
  • 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. PubMed 35380982 ↗
  • 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. PubMed 35900323 ↗
  • 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. PubMed 38561283 ↗
  • 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. PubMed 34558612 ↗
  • 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. PubMed 30865224 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06955286
Lead sponsor
Qifu Li
Responsible party
Qifu Li (Primary investigator, Chongqing Medical University) — Sponsor-investigator
First posted
May 2, 2025
Start date
Jan 2, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 1, 2026

Study contacts

Li Qifu, PhD
Contact
liqifu@yeah.net
+86-023-89011552

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hyperaldosteronism→

Other studies from this sponsor

Qifu Li

Start the discussion