NCT00917345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

1 year

First QC Date

June 8, 2009

Last Update Submit

June 9, 2009

Conditions

Primary Aldosteronism

Keywords

ARCPRAprimary aldosteronismcaptopril testaldosterone-renin ratioPrimary aldosteronism (PA) than PRA and establish thresholds for the diagnosis using ARC.

Outcome Measures

Primary Outcomes (1)

  • Determination of ARC in contrast to PRA offers advantage with regard to processing and standardization, knowing the postcaptopril sensitivity and specificity

    1 day

Study Arms (2)

aldosteronism, hypertension

Drug: captopril test

hypertension

Drug: captopril test

Interventions

captopril testDRUG

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

aldosteronism, hypertensionhypertension

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were referred to the hypertension clinics for suspicious of aldosteronism after an initial evaluation, and recorded in the Taiwan Primary Aldosteronism Investigation (TAIPAI). The initial evaluation included (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. All patients with intention to confirm and received captopril test were recruited and data were prospectively collected.

You may qualify if:

  • age at onset younger than 35 years,
  • hypertension that is difficult to control after initiating therapy,
  • clinical occurrence of a hypertensive crisis,
  • the presence of hypokaliemia or metabolic alkalosis, or a random aldosterone-renin ration (ARR) \>30, and
  • evidence of adrenal incidentaloma and hypertension or hypokalemia.

You may not qualify if:

  • chronic kidney disease with elevated estimated glomerular filtration rate (\< 60, mL/min/1.73 m2)
  • liver disease with elevated GPT (\> 35)
  • heart failure
  • classified as more than NYHA II,
  • hyperthyroidism
  • malignancy with metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37334546DERIVED

  • 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.

    PMID: 20117105DERIVED

MeSH Terms

Conditions

HyperaldosteronismAIDS-Related Complex

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

VinCent Wu, MD

CONTACT

+886927223278q91421028@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

June 10, 2009

Record last verified: 2009-06

Locations

TW(1)