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

• Conditions: Hypertension; Primary Aldosteronism

• Registration Number: NCT04991961
• Lead Sponsor: Chongqing Medical University

Brief Summary

To evaluate the effect of anti-hypertensive medication on efficiency of primary aldosteronism screening 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）. However, some antihypertensive drugs may cause false positives and false negatives on ARR. Thus, America PA guidelines suggest that antihypertensive drugs should be withdraw or change therapy before screening.

But withdraw/changing the therapy before ARR is inconvenient for patients.

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

Study Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation	2 weeks	Consistent diagnosis after drug withdrawal
Missing Diagnosis	2 weeks	essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal
Misdiagnosis	2 weeks	primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.

Trial Locations

Locations (2)

Qifu Li; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China