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NCT Number: NCT04991961

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

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.

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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qifu Li, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

withdraw antihypertensive drugs

Diagnostic Test

patients need to withdraw of all antihypertensive drugs or change therapy to Doxazosin/Diltiazem for 2-4 weeks prior

Primary outcomes

  1. Confirmation

    Time frame: 2 weeks

    Consistent diagnosis after drug withdrawal

  2. Missing Diagnosis

    Time frame: 2 weeks

    essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal

  3. Misdiagnosis

    Time frame: 2 weeks

    primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Acronym: HASA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2021
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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