Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism (HASA)

August 10, 2025 updated by: Qifu Li, Chongqing Medical University

Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism：a Prospective Study

To evaluate the effect of anti-hypertensive medication on efficiency of primary aldosteronism screening and confirmatory test, and to determine the appropriate diagnostic cutoff value for Chinese hypertension patients during antihypertensive drugs therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aldosterone-Renin ratio (ARR)is currently the most reliable means available for screening for primary aldosterone（PA）while captopril challenging test is the widely used confirmatory test. However, some antihypertensive drugs may interfer aldosterone and renin levels. Thus, PA guidelines suggest that antihypertensive drugs should be withdraw or change therapy before screening.

But withdraw/changing the therapy is inconvenient for patients.

The investigators prepare to start a prospective study through recruiting hypertension patients, completing the ARR screening and captopril challenging test before and after withdraw/change therapy.

Study Type

Observational

Enrollment (Actual)

341

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 400016
        • Qifu Li

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

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients in the Department of Endocrinology and physical examination center of First Affiliated Hospital of CQMU who with hypertension, and under anti-hypertension medication therapy and being certificated with high risk factors of PA were recruited as the study group.

Description

Inclusion Criteria:

  • Persistent hypertension >150/100mmHg, including previously diagnosed grade 2 hypertension but well controlled by 1-2 drugs; newly diagnosed hypertension with 3 days blood pressure > 150 / 100mmHg
  • Resistant hypertension(combined with three antihypertensive drugs and one of them is diuretic but blood pressure is still greater than 140 / 90 mmHg ; or need to combined four anti-hypertensive drugs to control the blood pressure under 140 / 90 mmHg)
  • Family history of hypertension with early onset (< 40 years old)
  • Family history of hypertension with early onset (<40 years old) and cerebrovascular accident
  • Hypertension with spontaneous or diuretic hypokalemia
  • Hypertensive with adrenal incidentaloma
  • Hypertensive with OSAS
  • First-degree relatives of PA patients and with hypertension Stable antihypertensive medication therapy for more than 2 weeks, medication including：β-blockers, CCB, ACEi, ARB, MRA, and other diuretics.

Exclusion Criteria:

  • Patients hard to change or stop the medication for accomplish the screening test or diagnosis Unwilling to participate the study and refuse to sign on informed consent Patients who was diagnosed with other secondary hypertension Suspected with PA（rein concretion beyond the limit of normal reference range after stoping or changing the medication） Severe renal insufficiency （eGFR<30 ml/min/1.73m2）; pregnancy

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 and essential hypertensin group
patients will be diagnosed as PA or EH based on ARR and CCT off interfering meds
Diagnostic test: withdraw antihypertensive drugs
patients need to withdraw of all antihypertensive drugs or change therapy to Doxazosin/Diltiazem for 2-4 weeks prior
primary aldosteronism (PA) group and essential hypertension (EH) group
The diagnosis of PA was established based on an ARR ≥20 pg·ml-1/μIU·ml-1 off interfering medications plus one of the following criteria: (1) PAC post-CCT off interfering medications was over 110pg/mL; (2) PAC post-CCT off interfering medications ranged from 80 to 110 pg/mL, but PAC post-SSIT off interfering medications exceeded 80 pg/mL. In patients with an ARR of 10-20 pg·ml-1/μIU·ml-1 but with hypokalemia or adrenal nodules, PA was also diagnosed if the confirmatory test was positive. The diagnosis of EH was determined if PA was excluded.
Diagnostic test: withdraw antihypertensive drugs
patients need to withdraw of all antihypertensive drugs or change therapy to Doxazosin/Diltiazem for 2-4 weeks prior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation
Time Frame: 2 weeks
Consistent diagnosis after drug withdrawal
2 weeks
Missing Diagnosis
Time Frame: 2 weeks
essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal
2 weeks
Misdiagnosis
Time Frame: 2 weeks
primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.
2 weeks

Collaborators and Investigators

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

Sponsor

Chongqing Medical University

Investigators

  • Study Chair: Li Qifu, PhD, 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 (Actual)

September 15, 2020

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 10, 2025

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HASA-China2020

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

product manufactured in and exported from the U.S.

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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