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Prospective Evaluation of Confirmatory Testing For Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT04422756
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hypertension Canada
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
This study is to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose ACTH stimulation test for the diagnosis of primary aldosteronism.

Condition or disease Intervention/treatment
Primary Aldosteronism Diagnostic Test: Seated intravenous saline infusion test Diagnostic Test: Ultra low-dose ACTH stimulation test

Detailed Description:
This is a prospective study (with a target recruitment of 200 participants) designed to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose ACTH stimulation test for the diagnosis of primary aldosteronism, using disease-specific treatment response as a reference gold standard. Subjects consenting to study participation will undergo a standardized seated saline infusion test, followed by an ultra low-dose ACTH stimulation test. All participants also receive adrenal vein sampling. Individuals who have unilateral disease and desire surgery will receive adrenalectomy (as part of routine care) and the remaining subjects will receive medical treatment with a mineralocorticoid receptor antagonist. Response to targeted treatment will be considered the reference gold standard for the establishing the diagnosis of primary aldosteronism.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Confirmatory Testing For Primary Aldosteronism
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Seated intravenous saline infusion test
    The test will be conducted by infusing two litres of normal saline intravenously over 4 hours with the patient seated.Blood collection (for aldosterone, cortisol, renin, and electrolytes) will be performed at baseline and after completion of the infusion. Following infusion, plasma aldosterone levels <140 pmol/L will be considered as "negative," levels >280 pmol/L as "positive," and levels in between classified as indeterminate.
  • Diagnostic Test: Ultra low-dose ACTH stimulation test
    The test will be performed by injecting 0.03 mcg of ACTH intravenously. Blood collection (for aldosterone, cortisol, and renin) will be performed at baseline and after 15 minutes. We expect a "positive" response to correspond with a plasma aldosterone >2200 pmol/L and ARR >220 pmol/L/mIU/L following stimulation.


Primary Outcome Measures :
  1. Diagnostic accuracy of confirmatory testing (seated saline infusion test and the ultra low-dose ACTH stimulation test) [ Time Frame: The total study timeline will occur over 66 months. ]
    Measures of diagnostic accuracy, as summarized by receiver operating characteristic curve analyses.


Secondary Outcome Measures :
  1. The optimal cutoff value for confirmatory testing using clinically-important thresholds [ Time Frame: The total study timeline will occur over 66 months. ]
    Plasma aldosterone

  2. The optimal cutoff value for confirmatory testing using clinically-important thresholds [ Time Frame: The total study timeline will occur over 66 months. ]
    Aldosterone-to-renin ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertension individuals suspected of having primary aldosteronism.
Criteria

Inclusion Criteria:

  • Individuals with hypertension
  • Individuals with an elevated screening adrenal renin ration (ARR)
  • Individuals with high probability features of primary aldosteronism (e.g., resistant hypertension, spontaneous or diuretic-induced hypokalemia, and/or an adrenal nodule) with clinical indications for adrenal vein sampling and surgery (if appropriate).

Exclusion Criteria:

  • Individuals with chronic kidney disease (estimated glomerular filtration rate <40 mL/min/1.73m2),
  • Individuals with a history of heart failure, chronic edema, uncontrolled severe hypertension (systolic blood pressure >180 and/or diastolic blood pressure >110 mmHg), untreated hypokalemia, cortisol-secreting adrenal adenoma, and/or pheochromocytoma
  • Individual who previously received confirmatory testing.

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): NCT04422756


Contacts
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Contact: Alexander Leung, MD (403) 955-8358 aacleung@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Alexander Leung, MD    (403) 955-8358    aacleung@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Hypertension Canada
Investigators
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Principal Investigator: Alexander Leung, Asst. Prof University of Calgary
Publications:
Leung AA, Nerenberg K, Daskalopoulou SS, McBrien K, Zarnke KB, Dasgupta K, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P, Tremblay G, McLean D, Tobe SW, Ruzicka M, Burns KD, Vallée M, Prasad GV, Lebel M, Feldman RD, Selby P, Pipe A, Schiffrin EL, McFarlane PA, Oh P, Hegele RA, Khara M, Wilson TW, Penner SB, Burgess E, Herman RJ, Bacon SL, Rabkin SW, Gilbert RE, Campbell TS, Grover S, Honos G, Lindsay P, Hill MD, Coutts SB, Gubitz G, Campbell NR, Moe GW, Howlett JG, Boulanger JM, Prebtani A, Larochelle P, Leiter LA, Jones C, Ogilvie RI, Woo V, Kaczorowski J, Trudeau L, Petrella RJ, Hiremath S, Drouin D, Lavoie KL, Hamet P, Fodor G, Grégoire JC, Lewanczuk R, Dresser GK, Sharma M, Reid D, Lear SA, Moullec G, Gupta M, Magee LA, Logan AG, Harris KC, Dionne J, Fournier A, Benoit G, Feber J, Poirier L, Padwal RS, Rabi DM; CHEP Guidelines Task Force. Hypertension Canada's 2016 Canadian Hypertension Education Program Guidelines for Blood Pressure Measurement, Diagnosis, Assessment of Risk, Prevention, and Treatment of Hypertension. Can J Cardiol. 2016 May;32(5):569-88. doi: 10.1016/j.cjca.2016.02.066. Epub 2016 Mar 10.

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04422756    
Other Study ID Numbers: REB16-2322
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: March 2020
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
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases