Diagnosis of Primary Aldosteronism: Comparison of Post Captopril Active Renin Concentration and Plasma Renin Activity

NCT ID: NCT00917345

Last Updated: 2009-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-05-31

Brief Summary

Background: The most common pharmacologic test for diagnosis of primary aldosteronism (PA) is administration of captopril to examine whether abnormal aldosterone to plasma rennin activity (PRA)(ARR) persists, although active rennin concentration (ARC) in contrast to PRA may offers advantages with regard to processing and standardization.

Objective: To assess whether post captopril ARC offer any additional advantage in screening primary aldosteronism (PA) than PRA and establish thresholds for the diagnosis using ARC.

Detailed Description

Primary aldosteronism (PA), characterized by an inappropriate production of aldosterone, affects 5-13% of patients with hypertension(1, 2). The use of aldosterone-renin ratio (ARR) as screening test contributes to the increased diagnostic rate of this disease(2), but it is not standardized among laboratories. As the incidence of PA has increased since ARR has been used as a screening test (3, 4), the difficulty in establishing a diagnosis of PA may be encountered because of atypical manifestations. Administration of captopril to differentiate the normal renin-angiotensin- aldosterone axis from autonomous secretion of aldosterone has been proved to be a safe and effective test in confirmation of the diagnosis (5-8). Several studies have demonstrated that the ARR after a single dose of captopril is diagnostic (5-8) and as sensitive as the saline loading test for the identification of aldosterone- producing adenoma (APA)(8).

Active rennin concentration (ARC) is considerably easier to perform; being a single immunoradiometric assay as opposed to the initial generation of angiotensin I generated from angiotensinogen followed by radioimmunoassay of PRA(9). It was demonstrated as a reliable and convenient screening tool for ambulatory conditions, independent of body posture (10). Decreased angiotensinogen level is noted in pathological status ( e.g. liver cirrhosis, sever cardiac failure) (11, 12) that results in dissociate of PRA measurement. PAC when used in conjunction with aldosterone to produce an ARRARC , has been reported to classify aldosteronism correctly(13). Although PRA is highly sensitive, the measurement is time-consuming and measured values can vary considerably between laboratories(14). In aldosteronism with suppressed renin, the ratio of ARR is clearly dependent on the variants lower detection limit(15). Though determination of ARC in contrast to PRA offers advantage with regard to processing and standardization, knowing the postcaptopril sensitivity and specificity as well as the optimum cut off value of ARC is paramount (16) help to the diagnosis PA (15, 17, 18) and might serve better performance than ARRPRA.

Conditions

Primary Aldosteronism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

aldosteronism, hypertension

captopril test

Intervention Type: DRUG

The blood samplings were obtained one hour after the administration of 50 mg of captopril.The testing is performed in the morning on a seated ambulatory patient

hypertension

captopril test

Intervention Type: DRUG

The blood samplings were obtained one hour after the administration of 50 mg of captopril.The testing is performed in the morning on a seated ambulatory patient

Interventions

captopril test

The blood samplings were obtained one hour after the administration of 50 mg of captopril.The testing is performed in the morning on a seated ambulatory patient

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. age at onset younger than 35 years,

2. hypertension that is difficult to control after initiating therapy,

3. clinical occurrence of a hypertensive crisis,

4. the presence of hypokaliemia or metabolic alkalosis, or a random aldosterone-renin ration (ARR) >30, and

5. evidence of adrenal incidentaloma and hypertension or hypokalemia.

Exclusion Criteria

1. chronic kidney disease with elevated estimated glomerular filtration rate (< 60, mL/min/1.73 m2)

2. liver disease with elevated GPT (> 35)

3. heart failure

4. classified as more than NYHA II,

5. hyperthyroidism

6. malignancy with metastasis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

VinCent Wu, MD

Role: CONTACT

q91421028@ntu.edu.tw

+886927223278

Facility Contacts

VinCent Wu, MD

Role: primary

+886937223278

References

Sheu JY, Wang SM, Wu VC, Huang KH, Tseng CS, Lee YJ, Tsai YC, Lin YH, Chueh JS. Estimated glomerular filtration rate-dip after medical target therapy associated with increased mortality and cardiovascular events in patients with primary aldosteronism. J Hypertens. 2023 Sep 1;41(9):1401-1410. doi: 10.1097/HJH.0000000000003479. Epub 2023 Jun 8.

Reference Type: DERIVED

PMID: 37334546 (View on PubMed)

Wu VC, Kuo CC, Chang HW, Tsai CT, Lin CY, Lin LY, Lin YH, Wang SM, Huang KH, Fang CC, Ho YL, Liu KL, Chang CC, Chueh SC, Lin SL, Yen RF, Wu KD; TAIPAI study group. Diagnosis of primary aldosteronism: comparison of post-captopril active renin concentration and plasma renin activity. Clin Chim Acta. 2010 May 2;411(9-10):657-63. doi: 10.1016/j.cca.2010.01.027. Epub 2010 Feb 1.

Reference Type: DERIVED

PMID: 20117105 (View on PubMed)

Other Identifiers

200904076R

Identifier Type: -

Identifier Source: org_study_id