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

NCT04991961 | Completed DMC

• 1 other identifier: HASA-China2020
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Primary Aldosteronism

Keywords

hypertension; Aldosterone-Renin ratio; Primary aldosteronism

Outcome Measures

Primary Outcomes (3)

• Confirmation

  Consistent diagnosis after drug withdrawal

  2 weeks

• Missing Diagnosis

  essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal

  2 weeks

• Misdiagnosis

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

  2 weeks

Study Arms (2)

primary aldosteronism group and essential hypertensin group

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

Diagnostic Test: withdraw antihypertensive drugs

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

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.

Diagnostic Test: withdraw antihypertensive drugs

Interventions

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

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (2)

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (7)

• 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.

  PMID: 25993253 BACKGROUND

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 15681560 BACKGROUND

• 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.

  PMID: 11273868 BACKGROUND

• 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.

  PMID: 18855267 BACKGROUND

• 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.

  PMID: 30255616 BACKGROUND

• Li X, Liang J, Hu J, Ma L, Yang J, Zhang A, Jing Y, Song Y, Yang Y, Feng Z, Du Z, Wang Y, Luo T, He W, Shu X, Yang S, Li Q; Chongqing Primary Aldosteronism Study (CONPASS) Group. Screening for primary aldosteronism on and off interfering medications. Endocrine. 2024 Jan;83(1):178-187. doi: 10.1007/s12020-023-03520-6. Epub 2023 Oct 5.

  PMID: 37796417 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Li Qifu, PhD

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: September 15, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 14, 2025

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)