NCT00155064

Brief Summary

The tissue kallikrein-kinin (KKS) and renin-angiotension-aldosterone system (RAAS) had been implicated in regulating blood pressure and electrolyte homeostasis. Both of the KKS and RAAS may work coordinately to regulate salt metabolism, local blood flow. Thus, we conducted this study to elucidate, first, whether some alterations in components of the kallikrein-kinin system could do effect on aldosterone secretion. Previous study has shown the post captopril plasma aldosterone concentration (PAC)/ plasma rennin activity (PRA) ration (ARR) was a reliable method for diagnosis of primary aldosteronism (PA). The ARR change by angiotensin II receptor blockade was reported to be significantly higher than that by ACE inhibitor. This study assessed whether angiotensin II receptor blockade offers any additional advantage in the diagnosis of PA. Clinically we evaluated the sensitivity and specificity of captopril (angiotensin-converting enzyme inhibition) and losartan (angiotensin II type 1 receptor blocker) test in PA patient. This interaction mechanism, in term, could further explain the interaction of KKS and RAAS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

3.4 years

First QC Date

September 9, 2005

Last Update Submit

December 15, 2014

Conditions

Hyperaldosteronism

Keywords

Primary aldosteronismkallikreinaldosteronecaptopril

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of primary aldosteronism

Secondary Outcomes (1)

  • Subgroup analysis of primary aldosteronism

Interventions

captopril, Losartan (drug)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertension admitted for the diagnosis of primary aldosteronism

You may not qualify if:

  • Pregnant or lactating women. (Pre-menopause women, capable of bearing children will undergo pregnancy test), hypertension without discontinuous b-blocker, ACEI or ARB for more than 10 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

  • Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3. doi: 10.1161/01.hyp.37.6.1440.

    PMID: 11408392BACKGROUND

  • Dendorfer A, Wolfrum S, Dominiak P. Pharmacology and cardiovascular implications of the kinin-kallikrein system. Jpn J Pharmacol. 1999 Apr;79(4):403-26. doi: 10.1254/jjp.79.403.

    PMID: 10361880BACKGROUND

  • Hesse B, Rasmussen S, Lund JO, Christensen P, Damkjaer Nielsen M. Urinary excretion of kallikrein before and after operation for aldosterone-producing adenoma. Acta Med Scand. 1985;217(5):501-5. doi: 10.1111/j.0954-6820.1985.tb03253.x.

    PMID: 3895826BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

CaptoprilLosartanPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Kwan-Dun Wu, Md, PhD

    National Taiwan University Hospital

    STUDY CHAIR

  • Vin-Cent Wu, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

July 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

TW(1)