HypertensionHASANCT04991961
Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism
An observational study of Hypertension and Primary Aldosteronism, run by Chongqing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Hypertension, Primary Aldosteronism
- What is being tested?
- withdraw antihypertensive drugs
- How many people
- 341 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2020to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Qifu Li
Chongqing, Chongqing Municipality, 400016
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism：a Prospective Study
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.
Read the detailed 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.
- Conditions
- Hypertension, Primary Aldosteronism
- Being tested
- withdraw antihypertensive drugs
- Keywords
- hypertension, Aldosterone-Renin ratio, Primary aldosteronism
- Medical subject headings
- Hypertension, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdraw antihypertensive drugsDiagnostic test
patients need to withdraw of all antihypertensive drugs or change therapy to Doxazosin/Diltiazem for 2-4 weeks prior
| Study group | Role | What they receive |
|---|---|---|
| primary aldosteronism group and essential hypertensin group | patients will be diagnosed as PA or EH based on ARR and CCT off interfering meds Receives: 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. Receives: Diagnostic Test: withdraw antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation
Consistent diagnosis after drug withdrawal
Measured: 2 weeks
Missing Diagnosis
essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal
Measured: 2 weeks
Misdiagnosis
primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start15 Sep 2020
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
- Investigators
- Li Qifu, PhD, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991961
- Sponsor's protocol ID
- HASA-China2020
- Acronym
- HASA
- Status last verified
- Sep 2020
- First submitted
- 28 Jul 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25993253Funder 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.
PubMed 26934393Gallay 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.
PubMed 11273868Niizuma 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.
PubMed 18855267Young 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.
PubMed 30255616Schwartz 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.
PubMed 15681560Li 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.
PubMed 37796417
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism：a Prospective Study
- ClinicalTrials.gov ID
- NCT04991961
- Acronym / sponsor ID
- HASA / HASA-China2020
- Conditions
- Hypertension, Primary Aldosteronism
- Keywords
- hypertension, Aldosterone-Renin ratio, Primary aldosteronism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary aldosteronism group and essential hypertensin group | – | Diagnostic Test: withdraw antihypertensive drugspatients will be diagnosed as PA or EH based on ARR and CCT off interfering meds |
| primary aldosteronism (PA) group and essential hypertension (EH) group | – | Diagnostic Test: withdraw antihypertensive drugsThe 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. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| withdraw antihypertensive drugspatients need to withdraw of all antihypertensive drugs or change therapy to Doxazosin/Diltiazem for 2-4 weeks prior | Diagnostic test | primary aldosteronism (PA) group and essential hypertension (EH) group, primary aldosteronism group and essential hypertensin group |
Primary outcome
Confirmation
Time frame: 2 weeks
Consistent diagnosis after drug withdrawal
Missing Diagnosis
Time frame: 2 weeks
essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal
Misdiagnosis
Time frame: 2 weeks
primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 25993253Viola 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.
- Background: PubMed 26934393Funder 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.
- Background: PubMed 11273868Gallay 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.
- Background: PubMed 18855267Niizuma 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.
- Background: PubMed 30255616Young 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.
- Results publication: PubMed 15681560Schwartz 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.
- Derived from this study: PubMed 37796417Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Qifu, PhD study chair
First Affiliated Hospital of Chongqing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Primary Aldosteronism, run by Chongqing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991961, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.