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

NCT ID: NCT06955286

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-02

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 these patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Aldosteronism Autonomous Cortisol Secretion Adrenal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients With Primary Aldosteronism Concurrent With or Without Autonomous Cortisol Secretion

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

complete ACTH stimulation test the day after surgery

Intervention Type DIAGNOSTIC_TEST

patients complete ACTH stimulation test on the one day after surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

complete ACTH stimulation test the day after surgery

patients complete ACTH stimulation test on the one day after surgery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* PA conccurent with or without autonomous cortisol secretion
* complete adrenalectomy
* complete ACTH stimulation test on the one day after surgery
* complete follow-up at 6,12 months after surgery

Exclusion Criteria

* Patients underwent partial adrenalectomy
* Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \<20 years, hypertension and hypokalemia, or with family history\]
* Suspicion of pheochromocytoma or adrenal carcinoma.
* Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb\<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m2) or Underweight (BMI≤18 kg/m2); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
* Patients with actively malignant tumor.
* Long- term use of glucocorticoids.
* Suspected PBMAH or PPNAD;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qifu Li

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Qifu Li

Primary investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li Qifu, PhD

Role: CONTACT

+86-023-89011552

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Li Qifu, PhD

Role: primary

+86-023-89011552

Yang Shuming, PhD

Role: backup

+86-023-89011552

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 35218017 (View on PubMed)

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.

Reference Type RESULT
PMID: 32327102 (View on PubMed)

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.

Reference Type RESULT
PMID: 21593113 (View on PubMed)

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.

Reference Type RESULT
PMID: 35418526 (View on PubMed)

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.

Reference Type RESULT
PMID: 37410097 (View on PubMed)

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.

Reference Type RESULT
PMID: 23385627 (View on PubMed)

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.

Reference Type RESULT
PMID: 35380982 (View on PubMed)

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.

Reference Type RESULT
PMID: 35900323 (View on PubMed)

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.

Reference Type RESULT
PMID: 38561283 (View on PubMed)

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.

Reference Type RESULT
PMID: 34558612 (View on PubMed)

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.

Reference Type RESULT
PMID: 30865224 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-040-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cushing's Disease Complications
NCT02568982 COMPLETED