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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04991961
Acronym
HASA
Enrollment
341
Registered
2021-08-05
Start date
2020-09-15
Completion date
2024-10-31
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Primary Aldosteronism

Keywords

hypertension, Aldosterone-Renin ratio, Primary aldosteronism

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTwithdraw antihypertensive drugs

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

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Confirmation2 weeksConsistent diagnosis after drug withdrawal
Missing Diagnosis2 weeksessential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal
Misdiagnosis2 weeksprimary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026