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

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ClinicalTrials.gov Identifier: NCT04991961
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

Brief Summary:
To evaluate the effect of anti-hypertensive medication on efficiency of primary aldosteronism screening test, and to determine the appropriate diagnostic cutoff valuefor Chinese hypertension patients during antihypertensive drugs therapy.

Condition or disease Intervention/treatment
Hypertension Primary Aldosteronism Diagnostic Test: withdraw antihypertensive drugs

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.

we 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.

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism:a Prospective Study
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021



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


Primary Outcome Measures :
  1. Confirmation [ Time Frame: 2 weeks ]
    Consistent diagnosis after drug withdrawal

  2. Missing Diagnosis [ Time Frame: 2 weeks ]
    essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal

  3. Misdiagnosis [ Time Frame: 2 weeks ]
    primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.


Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 hypertention(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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04991961


Contacts
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Contact: Li Qifu, PhD +86-023-89011552 liqifu@yeah.net
Contact: Yang Shuming, PhD +86-023-89011552 443068494@qq.com

Locations
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China, Chongqing
Qifu Li Recruiting
Chongqing, Chongqing, China, 400016
Contact: Qifu Li, PhD    +86 23 89011552    liqifu@yeah.net   
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400016
Contact: Shumin Yang, PhD    02389011552    443068494@qq.com   
Sub-Investigator: Shumin Yang, PhD         
Sub-Investigator: Qingfeng Cheng, PhD         
Sub-Investigator: Jinbo Hu, MD         
Sub-Investigator: Yue Wang, MD         
Principal Investigator: Qifu Li, PhD         
Sub-Investigator: Zhihong Wang, PhD         
Sub-Investigator: Jian Long, PhD         
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Study Chair: Li Qifu, PhD First Affiliated Hospital of Chongqing Medical University
Publications of Results:
Other Publications:
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Responsible Party: Qifu Li, Prof., Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04991961    
Other Study ID Numbers: HASA-China2020
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qifu Li, Chongqing Medical University:
hypertension
Aldosterone-Renin ratio
Primary aldosteronism
Additional relevant MeSH terms:
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Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Antihypertensive Agents