Primary Aldosteronism LC-MS/MS-specific Cutoffs

NCT05959863 | Completed

• 1 other identifier: PM-China 2023
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

Diagnostic; Multicenter study

Outcome Measures

Primary Outcomes (2)

• 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 aldosterone-to-renin ratio.

  At baseline without medication interfering.

• 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 Outcomes (2)

• Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism.

  At baseline with medication interfering.

• compare the different criteria of Captopril Challenge Test for the diagnosis of primary aldosteronism.

  2 hours after the captopril challenge test without medication interfering.

Study Arms (2)

Primary Aldosteronism Group

Patients diagnosed with primary aldosteronism

Diagnostic Test: Captopril Challenge Test

Essential Hypertension Group

Patients diagnosed with essential hypertension

Diagnostic Test: Captopril Challenge Test

Interventions

Captopril Challenge Test DIAGNOSTIC_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.

Essential Hypertension Group; Primary Aldosteronism Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study intends to include patients taking hypertension medication at each center between June 2023 and July 2024 with subjects signing written informed consent.

You may qualify if:

• Age is between 18-75 years old.
• 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;
• Recent and stable use of antihypertensive drugs for more than 2 weeks, The drug types may include: β receptor blockers, CCB(calcium channel blockers), angiotension converting enzyme inhibitors(ACEi), Angiotensin Receptor Blocker(ARB), mineralocorticoid receptor antagonists(MRA), and other diuretics.

You may not qualify if:

• Patients who are unwilling to participate and complete the study or refuse to sign a written informed consent for the study;
• Patients diagnosed with other secondary hypertension (such as renal hypertension, renal artery stenosis, pheochromocytoma, Cushing's syndrome, etc.);
• 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);
• 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;
• Patients who are pregnant or who are currently being treated with sex hormones and glucocorticoids;
• incurable malignancy;
• Other reasons make it difficult to change or stop the drug to complete the diagnosis.

Sponsors & Collaborators

• Chongqing Medical University: lead
• Chinese PLA General Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (2)

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

Location

Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

Related Publications (6)

• 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.

  PMID: 22238407 BACKGROUND

• 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

• 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.

  PMID: 33112272 RESULT

• 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.

  PMID: 30255616 RESULT

• 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 to action and a lifecourse strategy to address the global burden of raised blood pressure on current and future generations: the Lancet Commission on hypertension. Lancet. 2016 Nov 26;388(10060):2665-2712. doi: 10.1016/S0140-6736(16)31134-5. Epub 2016 Sep 23. No abstract available.

  PMID: 27671667 RESULT

• 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.

  PMID: 25619896 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma

MeSH Terms

Conditions

Hyperaldosteronism; Disease

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qifu Li

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 25, 2023
• Study Start: June 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)