Primary Aldosteronism LC-MS/MS-specific Cutoffs

Primary Aldosteronism Clinical Trial

— PM  

Official title:

LC-MS/MS-specific Cutoffs for Screening and Confirmatory Testing of Primary Aldosteronism: A Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959863
• Other study ID #: PM-China 2023
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Chongqing Medical University
• Contact: Qifu Li, PhD
• Phone: 18696676815
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.

Description:

Plasma aldosterone concentration and plasma renin activity / concentration measurement are important for early screening and diagnosis of Primary Aldosteronism (PA), most measurement methods are currently based on chemiluminescence, which may be cross-reactivity with other compounds and metabolites, leading to misdiagnosis or missed diagnosis of PA patients. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases. However, it is unknown for the cut-offs of PA screening and CCT test based on this technology in China. Therefore, the purpose of this study is to establish the screening and CCT cut-off point for primary aldosteronism based on LC-MS/MS technique at multicenter in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age is between 18-75 years old.

2. Hypertension patients with high risk factors for PA (meeting one of the following criteria): a.Persistent hypertension (> 150 / 100mmHg); b. Refractory hypertension (combined with 3 antihypertensive drugs and one used as a diuretic,Blood pressure is still greater than 140 / 90 mmHg or four antihypertensive drugs are needed to control blood pressure of less than 140 / 90 mmHg); c.Hypertension with adrenal accidental tumor; d.Hypertension is associated with hypokalaemia;

3. Recent and stable use of antihypertensive drugs for more than 2 weeks, The drug types may include: ß receptor blockers, CCB(calcium channel blockers), angiotension converting enzyme inhibitors(ACEi), Angiotensin Receptor Blocker(ARB), mineralocorticoid receptor antagonists(MRA), and other diuretics.

Exclusion Criteria: a.Patients who are unwilling to participate and complete the study or refuse to sign a written informed consent for the study; b.Patients diagnosed with other secondary hypertension (such as renal hypertension, renal artery stenosis, pheochromocytoma, Cushing's syndrome, etc.); c. Combined with severe renal insufficiency eGFR <30 ml/min / 1.73 m2, Or patients with liver insufficiency OR liver failure (Alanine aminotransferase and / or aspartate aminotransferase increased 2.5 times above the upper limit of normal); d. Clinical assessment of a dressing change risk, Including: Heart failure (NYHA stage grade II or above), any one or more of the stroke, myocardial infarction, and unstable angina pectoris diagnosed within three months; e. Patients who are pregnant or who are currently being treated with sex hormones and glucocorticoids; f.incurable malignancy; g. Other reasons make it difficult to change or stop the drug to complete the diagnosis.

Discontinuation criteria:Study discontinuation means that the clinical study has not yet been completed per protocol,Stop it all halfway through it.

1. If major safety problems occur in the study, should be suspended in time;

2. The sponsor requested the suspension of the study

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Diagnostic Test:
• Captopril Challenge Test
Patients received 50 mg captopril orally in the morning after sitting or standing for at least two hours. PAC and PRC were measured using mass spectrometry two hours after administration of capopril.

Locations

Country	Name	City	State
China	Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Qifu Li	Chongqing	Chongqing

Sponsors (4)

Lead Sponsor	Collaborator
Chongqing Medical University	Chinese Academy of Medical Sciences, Fuwai Hospital, Chinese PLA General Hospital, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Fuss CT, Brohm K, Kurlbaum M, Hannemann A, Kendl S, Fassnacht M, Deutschbein T, Hahner S, Kroiss M. Confirmatory testing of primary aldosteronism with saline infusion test and LC-MS/MS. Eur J Endocrinol. 2021 Jan;184(1):167-178. doi: 10.1530/EJE-20-0073. — View Citation

Mulatero P, di Cella SM, Monticone S, Schiavone D, Manzo M, Mengozzi G, Rabbia F, Terzolo M, Gomez-Sanchez EP, Gomez-Sanchez CE, Veglio F. 18-hydroxycorticosterone, 18-hydroxycortisol, and 18-oxocortisol in the diagnosis of primary aldosteronism and its subtypes. J Clin Endocrinol Metab. 2012 Mar;97(3):881-9. doi: 10.1210/jc.2011-2384. Epub 2012 Jan 11. — View Citation

Olsen MH, Angell SY, Asma S, Boutouyrie P, Burger D, Chirinos JA, Damasceno A, Delles C, Gimenez-Roqueplo AP, Hering D, Lopez-Jaramillo P, Martinez F, Perkovic V, Rietzschel ER, Schillaci G, Schutte AE, Scuteri A, Sharman JE, Wachtell K, Wang JG. A call t — View Citation

Rehan M, Raizman JE, Cavalier E, Don-Wauchope AC, Holmes DT. Laboratory challenges in primary aldosteronism screening and diagnosis. Clin Biochem. 2015 Apr;48(6):377-87. doi: 10.1016/j.clinbiochem.2015.01.003. Epub 2015 Jan 22. — View Citation

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 A — View Citation

Young WF Jr. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med. 2019 Feb;285(2):126-148. doi: 10.1111/joim.12831. Epub 2018 Sep 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism.	Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.Plasma aldosterone concentration and plasma renin activity will be combined and reported as an ARR in pg·L/ml·mU.	At baseline without medication interfering.
Primary	Establish a LC-MS/MS assay-specific cut-off point of CCT without medication interfering for primary aldosteronism.	Measure the plasma aldosterone concentration by LC-MS/MS.	2 hours after the captopril challenge test without medication interfering.
Secondary	Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism.	Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.; Plasma aldosterone concentration and plasma renin activity will be combined and reported as an ARR in pg·L/ml·mU.	At baseline with medication interfering.