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

Hypertension Clinical Trial

— HASA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991961
• Other study ID #: HASA-China2020
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Chongqing Medical University
• Contact: Li Qifu, PhD
• Phone: +86-023-89011552
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

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:ß-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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism

Intervention

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

Locations

Country	Name	City	State
China	Qifu Li	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation	Consistent diagnosis after drug withdrawal	2 weeks
Primary	Missing Diagnosis	essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal	2 weeks
Primary	Misdiagnosis	primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.	2 weeks