Primary AldosteronismNCT00917345
Diagnosis of Primary Aldosteronism: Comparison of Post Captopril Active Renin Concentration and Plasma Renin Activity
An observational study of Primary Aldosteronism, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- captopril test
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
VinCent Wu, MD, +886937223278
About this study
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.
Read the 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
- Being tested
- captopril test
- Keywords
- ARC, PRA, primary aldosteronism, captopril test, aldosterone-renin ratio, Primary aldosteronism (PA) than PRA and establish thresholds for the diagnosis using ARC.
- Medical subject headings
- Hyperaldosteronism, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| aldosteronism, hypertension | Not described Receives: Drug: captopril test | |
| hypertension | Not described Receives: Drug: captopril test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of ARC in contrast to PRA offers advantage with regard to processing and standardization, knowing the postcaptopril sensitivity and specificity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917345
- Sponsor's protocol ID
- 200904076R
- Status last verified
- Jun 2009
- First submitted
- 8 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37334546Wu 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.
PubMed 20117105
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Primary Aldosteronism: Comparison of Post Captopril Active Renin Concentration and Plasma Renin Activity
- ClinicalTrials.gov ID
- NCT00917345
- Acronym / sponsor ID
- 200904076R
- Conditions
- Primary Aldosteronism
- Keywords
- ARC, PRA, primary aldosteronism, captopril test, aldosterone-renin ratio, Primary aldosteronism (PA) than PRA and establish thresholds for the diagnosis using ARC.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aldosteronism, hypertension | – | Drug: captopril test |
| hypertension | – | Drug: captopril test |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| captopril testThe 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 | Drug | aldosteronism, hypertension, hypertension |
Primary outcome
Determination of ARC in contrast to PRA offers advantage with regard to processing and standardization, knowing the postcaptopril sensitivity and specificity
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
- Derived from this study: PubMed 37334546Sheu 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.
- Derived from this study: PubMed 20117105Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VinCent Wu, MD (+886927223278, q91421028@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of ARC in contrast to PRA offers advantage with regard to processing and standardization, knowing the postcaptopril sensitivity and specificity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917345, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2009.