Clinical trial NCT04991961: Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism
Official title: Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism：a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Primary Aldosteronism
Keywords: hypertension
Aldosterone-Renin ratio
Primary aldosteronism
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 330
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirmation
timeFrame: 2 weeks
measure: Missing Diagnosis
timeFrame: 2 weeks
measure: Misdiagnosis
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Qifu Li
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Li Qifu, PhD
role: STUDY_CHAIR
References:
citation: Viola A, Monticone S, Burrello J, Buffolo F, Lucchiari M, Rabbia F, Williams TA, Veglio F, Mengozzi G, Mulatero P. Renin and aldosterone measurements in the management of arterial hypertension. Horm Metab Res. 2015 Jun;47(6):418-26. doi: 10.1055/s-0035-1548868. Epub 2015 May 8.
citation: Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
citation: Gallay BJ, Ahmad S, Xu L, Toivola B, Davidson RC. Screening for primary aldosteronism without discontinuing hypertensive medications: plasma aldosterone-renin ratio. Am J Kidney Dis. 2001 Apr;37(4):699-705. doi: 10.1016/s0272-6386(01)80117-7.
citation: Niizuma S, Nakahama H, Kamide K, Fukuchi K, Iwanaga Y, Nakata H, Yoshihara F, Horio T, Nakamura S, Kawano Y. The cutoff value of aldosterone-to-renin ratio for the diagnosis of primary aldosteronism in patients taking antihypertensive medicine. Clin Exp Hypertens. 2008 Oct;30(7):640-7. doi: 10.1080/10641960802443282.
citation: Young WF Jr. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med. 2019 Feb;285(2):126-148. doi: 10.1111/joim.12831. Epub 2018 Sep 25.
citation: Schwartz GL, Turner ST. Screening for primary aldosteronism in essential hypertension: diagnostic accuracy of the ratio of plasma aldosterone concentration to plasma renin activity. Clin Chem. 2005 Feb;51(2):386-94. doi: 10.1373/clinchem.2004.041780.