Primary Aldosteronism LC-MS/MS-specific Cutoffs (PM)

July 24, 2023 updated by: Qifu Li, Chongqing Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China, 400016
        • Recruiting
        • Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • Qifu Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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: β 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Aldosteronism Group
Patients diagnosed with primary aldosteronism
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.
Essential Hypertension Group
Patients diagnosed with essential hypertension
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism.
Time Frame: At baseline without medication interfering.
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.
Establish a LC-MS/MS assay-specific cut-off point of CCT without medication interfering for primary aldosteronism.
Time Frame: 2 hours after the captopril challenge test without medication interfering.
Measure the plasma aldosterone concentration by LC-MS/MS.
2 hours after the captopril challenge test without medication interfering.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism.
Time Frame: At baseline with medication interfering.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Collaborators

Chinese PLA General Hospital
Tianjin Medical University General Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Chair: Qifu Li, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-China 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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