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

Chongqing Medical University

Status: Completed

Conditions: Hypertension; Primary Aldosteronism

Treatments: Diagnostic Test: withdraw antihypertensive drugs

Study type: Observational

Funder types: Other

Identifiers

NCT04991961

HASA-China2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

341 participants in 2 patient groups

primary aldosteronism group and essential hypertensin group

Description:

patients will be diagnosed as PA or EH based on ARR and CCT off interfering meds

Treatment:

Diagnostic Test: withdraw antihypertensive drugs

primary aldosteronism (PA) group and essential hypertension (EH) group

Description:

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.

Treatment:

Diagnostic Test: withdraw antihypertensive drugs