Study Results
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Basic Information
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RECRUITING
406 participants
OBSERVATIONAL
2025-04-15
2026-12-30
Brief Summary
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In this study, approximately 406 participants (ages 18-75) with diagnosed hypertension and on at least one interfering antihypertensive drug (such as ACE inhibitors, ARBs, beta-blockers, diuretics, or calcium channel blockers) will be enrolled at the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University. Each participant will undergo two rounds of blood sampling-first while continuing their usual antihypertensive regimen (the "on-medication" state) and second following a standardized washout/switch period (the "standard state"), if medically feasible. At both stages, levels of plasma aldosterone, renin, and a broad panel of adrenal steroid hormones will be measured by liquid chromatography-tandem mass spectrometry.
By comparing diagnostic performance (e.g., sensitivity, specificity, and area under the receiver operating characteristic curve) of the steroid-based screening versus the ARR, the study seeks to determine whether steroid profiling improves accuracy under real-world treatment conditions. Findings may help refine PA screening strategies, reduce the need for extensive medication adjustments, and contribute to better clinical management of hypertension.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PA Group
Participants with confirmed primary aldosteronism (PA)
Steroid-Based Screening (LC-MS/MS)
This diagnostic intervention is a liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based steroid profiling assay. It measures a panel of 18 adrenal steroid hormones (e.g., aldosterone, 18-hydroxycortisol, 18-oxocortisol, corticosterone) from plasma samples. In this study, it is used to screen for Primary Aldosteronism (PA) while patients remain on their usual antihypertensive medications. By comparing these steroid profiles against standard aldosterone-renin measurements, the method aims to reduce the need for medication washout and improve diagnostic accuracy for PA.
EH Group
Participants with essential hypertension (EH)
Steroid-Based Screening (LC-MS/MS)
This diagnostic intervention is a liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based steroid profiling assay. It measures a panel of 18 adrenal steroid hormones (e.g., aldosterone, 18-hydroxycortisol, 18-oxocortisol, corticosterone) from plasma samples. In this study, it is used to screen for Primary Aldosteronism (PA) while patients remain on their usual antihypertensive medications. By comparing these steroid profiles against standard aldosterone-renin measurements, the method aims to reduce the need for medication washout and improve diagnostic accuracy for PA.
Interventions
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Steroid-Based Screening (LC-MS/MS)
This diagnostic intervention is a liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based steroid profiling assay. It measures a panel of 18 adrenal steroid hormones (e.g., aldosterone, 18-hydroxycortisol, 18-oxocortisol, corticosterone) from plasma samples. In this study, it is used to screen for Primary Aldosteronism (PA) while patients remain on their usual antihypertensive medications. By comparing these steroid profiles against standard aldosterone-renin measurements, the method aims to reduce the need for medication washout and improve diagnostic accuracy for PA.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with hypertension, defined as a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg measured on at least two different days.
3. Currently receiving at least one antihypertensive medication that interferes with aldosterone or renin (ACEI/ARB, β-blockers, dihydropyridine CCBs, or diuretics including MRA) for ≥4 consecutive weeks.
4. Fully informed about the study procedures and risks, and willing to participate by signing a written informed consent form.
Exclusion Criteria
2. Severe cardiac, hepatic, or renal impairment or serious infections, including but not limited to New York Heart Association (NYHA) Class III-IV heart failure, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2.5 times the upper limit of normal, estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m², or severe infections (e.g., diabetic foot, sepsis, pneumonia, refractory infections).
3. History of major cardiovascular or cerebrovascular events within the past 3 months.
4. Pregnant or breastfeeding women.
5. Currently using medications (other than the listed antihypertensives) that may affect aldosterone or renin secretion, including but not limited to sex hormones (e.g., oral contraceptives, estrogen replacement therapy), glucocorticoids (e.g., prednisone, dexamethasone), nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or antipsychotics (e.g., chlorpromazine, olanzapine).
6. Individuals lacking or having restricted capacity for independent decision-making or action.
7. History of psychiatric disorders.
8. Poor compliance likely to compromise study completion.
18 Years
75 Years
ALL
No
Sponsors
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Qifu Li
OTHER
Responsible Party
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Qifu Li
Chief Physician, Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University.
Principal Investigators
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Qifu Li, MD, PhD, Chief Physician
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Locations
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Shumin Yang, MD, PhD, Chief Physician
Role: CONTACT
Facility Contacts
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References
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Constantinescu G, Gruber S, Fuld S, Peitzsch M, Schulze M, Remde H, Kurzinger L, Yang J, Yen T, Williams TA, Muller L, Reincke M, Lenders JWM, Beuschlein F, Pamporaki C, Eisenhofer GF. Steroidomics-Based Screening for Primary Aldosteronism: Impact of antihypertensive Drugs. Hypertension. 2024 Oct;81(10):2060-2071. doi: 10.1161/HYPERTENSIONAHA.124.23029. Epub 2024 Jul 31.
Eisenhofer G, Duran C, Cannistraci CV, Peitzsch M, Williams TA, Riester A, Burrello J, Buffolo F, Prejbisz A, Beuschlein F, Januszewicz A, Mulatero P, Lenders JWM, Reincke M. Use of Steroid Profiling Combined With Machine Learning for Identification and Subtype Classification in Primary Aldosteronism. JAMA Netw Open. 2020 Sep 1;3(9):e2016209. doi: 10.1001/jamanetworkopen.2020.16209.
Li X, Liang J, Hu J, Ma L, Yang J, Zhang A, Jing Y, Song Y, Yang Y, Feng Z, Du Z, Wang Y, Luo T, He W, Shu X, Yang S, Li Q; Chongqing Primary Aldosteronism Study (CONPASS) Group. Screening for primary aldosteronism on and off interfering medications. Endocrine. 2024 Jan;83(1):178-187. doi: 10.1007/s12020-023-03520-6. Epub 2023 Oct 5.
Liu X, Hao S, Bian J, Lou Y, Zhang H, Wu H, Cai J, Ma W. Performance of Aldosterone-to-renin Ratio Before Washout of Antihypertensive Drugs in Screening of Primary Aldosteronism. J Clin Endocrinol Metab. 2024 Nov 18;109(12):e2302-e2308. doi: 10.1210/clinem/dgae094.
Fischer E, Beuschlein F, Bidlingmaier M, Reincke M. Commentary on the Endocrine Society Practice Guidelines: Consequences of adjustment of antihypertensive medication in screening of primary aldosteronism. Rev Endocr Metab Disord. 2011 Mar;12(1):43-8. doi: 10.1007/s11154-011-9163-7.
Mulatero P, Monticone S, Deinum J, Amar L, Prejbisz A, Zennaro MC, Beuschlein F, Rossi GP, Nishikawa T, Morganti A, Seccia TM, Lin YH, Fallo F, Widimsky J. Genetics, prevalence, screening and confirmation of primary aldosteronism: a position statement and consensus of the Working Group on Endocrine Hypertension of The European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1919-1928. doi: 10.1097/HJH.0000000000002510.
Griffin TP, Browne GA, Wall D, Dennedy MC, O'Shea PM. A cross-sectional study of the effects of beta-blocker therapy on the interpretation of the aldosterone/renin ratio: can dosing regimen predict effect? J Hypertens. 2016 Feb;34(2):307-15. doi: 10.1097/HJH.0000000000000775.
Browne GA, Griffin TP, O'Shea PM, Dennedy MC. beta-Blocker withdrawal is preferable for accurate interpretation of the aldosterone-renin ratio in chronically treated hypertension. Clin Endocrinol (Oxf). 2016 Mar;84(3):325-31. doi: 10.1111/cen.12882. Epub 2015 Sep 22.
Mulatero P, Rabbia F, Milan A, Paglieri C, Morello F, Chiandussi L, Veglio F. Drug effects on aldosterone/plasma renin activity ratio in primary aldosteronism. Hypertension. 2002 Dec;40(6):897-902. doi: 10.1161/01.hyp.0000038478.59760.41.
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.
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.
Calhoun DA, Nishizaka MK, Zaman MA, Thakkar RB, Weissmann P. Hyperaldosteronism among black and white subjects with resistant hypertension. Hypertension. 2002 Dec;40(6):892-6. doi: 10.1161/01.hyp.0000040261.30455.b6.
Brown JM, Siddiqui M, Calhoun DA, Carey RM, Hopkins PN, Williams GH, Vaidya A. The Unrecognized Prevalence of Primary Aldosteronism: A Cross-sectional Study. Ann Intern Med. 2020 Jul 7;173(1):10-20. doi: 10.7326/M20-0065. Epub 2020 May 26.
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.
Choy KW, Fuller PJ, Russell G, Li Q, Leenaerts M, Yang J. Primary aldosteronism. BMJ. 2022 Apr 20;377:e065250. doi: 10.1136/bmj-2021-065250. No abstract available.
Other Identifiers
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SAFE Study
Identifier Type: -
Identifier Source: org_study_id
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