Sparing confirmatory testing in primary aldosteronism: the combination of renin, aldosterone and potassium levels
| ISRCTN | ISRCTN34186253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34186253 |
| Secondary identifying numbers | SL-22004 |
- Submission date
- 13/08/2023
- Registration date
- 16/08/2023
- Last edited
- 24/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Primary aldosteronism is a condition where the body produces too much aldosterone, a hormone that controls salt and water balance. The diagnosis process includes several steps: first, identifying potential cases through testing, then confirming the cases, and finally categorizing the specific subtype. Sometimes, in specific situations where there's low potassium, very low renin levels, and high PAC (aldosterone concentration), further tests might not be needed. However, the evidence for this is not very strong.
This study aimed to assess a simpler way to confirm primary aldosteronism without needing additional tests. It did this by looking at how well different predefined levels of PAC, along with suppressed renin and low potassium, can accurately diagnose the condition.
Who can participate?
Participants aged 18 years and above who underwent saline infusion test between January 2010 and March 2024 will be included.
What does the study involve?
A retrospective electronic chart review.
What are the possible benefits and risks of participating?
None.
Where is the study run from?
St. Luke's Medical Center-Quezon City (Philippines).
When is the study starting and how long is it expected to run for?
January 2022 to March 2024
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Dr. Albert Macaire C. Ong Lopez, albertmacaireonglopez@outlook.com
Contact information
Principal Investigator
St. Luke's Medical Center - Quezon City
Section of Endocrinology, Diabetes and Metabolism
279 E Rodriguez Sr. Ave
Quezon City
1112
Philippines
 ORCID ID |
0000-0003-4889-3226 |
|---|---|
| Phone | +63 (02)8723 0101 |
| albertmacaireonglopez@outlook.com |
Study information
| Study design | Multicenter retrospective diagnostic accuracy cohort-selected cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Sparing Confirmatory Testing In Primary Aldosteronism (SCIPA): A Multicenter Retrospective Diagnostic Accuracy Study |
| Study acronym | SCIPA |
| Study hypothesis | A hypertensive patient with screening results of baseline plasma aldosterone concentration > 15 ng/dL, suppressed plasma renin activity and spontaneous hypokalemia confirms primary aldosteronism disease and may not do dynamic testing |
| Ethics approval(s) |
Approved 14/02/2022, St. Luke’s Institutional Ethics Review Committee (IERC) (279 E Rodriguez Sr. Ave, Quezon City, 1112 Metro Manila, Quezon City, 1112, Philippines; +63 87230101; ethicsreview@stlukes.com.ph), ref: SL-22004 |
| Condition | Primary aldosteronism |
| Intervention | Baseline clinical and laboratory data will be retrieved from eligible patients who underwent saline suppression testing via the electronic medical records. The saline suppression test will serve as the reference standard which is used to confirm the presence or absence of primary aldosteronism disease. The initial screening laboratory blood exams shall include the baseline plasma renin activity, baseline plasma aldosterone concentration, and serum potassium level. Other data such as abdominal CT-scan findings and other surgical and/or histopathology results will likewise be obtained. The index test to be evaluated comprises the combination of baseline plasma aldosterone concentration (PAC) at different pre-specified cutoffs points (> 10, >15, >20, & >25 ng/dL), with suppressed baseline plasma renin activity (PRA) (at least less than 1.0 ng/mL/hr) and presence of spontaneous hypokalemia. For the saline infusion test protocol, patients remained in supine position for at least 1 hour prior to saline infusion. Samples of plasma aldosterone and serum potassium were drawn at baseline. Afterwards, 0.9% sodium chloride were infused at rate of 500 ml per hr over 4 hours for a total of 2 liters. At the end of infusion, repeat plasma aldosterone and serum potassium were extracted. A positive test result is defined as post saline-infusion plasma aldosterone levels of >10 ng/dL or a decrease of <50% of the post-saline infusion plasma aldosterone. |
| Intervention type | Other |
| Primary outcome measure | Aldosterone elevation, plasma renin activity, and hypokalemia obtained at baseline (“screening values’) through electronic health records. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 04/01/2022 |
| Overall study end date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 157 |
| Total final enrolment | 133 |
| Participant inclusion criteria | Current inclusion criteria as of 21/06/2024: Patients above 18 years of age who underwent saline infusion test between January 2010 and March 2024 will be included in this study. Previous inclusion criteria: Patients above 18 years of age who underwent saline infusion test between January 2010 and July 2023 will be included in this study. |
| Participant exclusion criteria | Those who did not complete the saline infusion test or did not comply with the saline infusion protocol will be excluded |
| Recruitment start date | 01/01/2010 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- Philippines
Study participating centres
Quezon City
1112
Philippines
Rizal Drive corner 32nd Street
Bonifacio Global City
Taguig City
1634
Philippines
Legaspi Village
Makati City
1229
Philippines
Sponsor information
Hospital/treatment centre
279 E Rodriguez Sr. Ave
Quezon City
1112
Philippines
| Phone | +63 87230101 |
|---|---|
| ethicsreview@stlukes.com.ph | |
| Website | https://www.stlukes.com.ph/ |
"ROR" |
https://ror.org/02h4kdd20 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Albert Macaire C. Ong Lopez (albertmacaireonglopez@outlook.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 14/10/2022 | 16/08/2023 | No | No |
| Basic results | 04/09/2023 | No | No | ||
| Basic results | 21/06/2024 | 21/06/2024 | No | No |
Additional files
Editorial Notes
24/06/2024: Ethics approval details added. The total final enrolment was changed from 120 to 133.
21/06/2024: The following changes were made to the study record:
1. The scientific title was changed from 'Sparing Confirmatory Testing In Primary Aldosteronism: A Multicenter Diagnostic Accuracy Study' to 'Sparing Confirmatory Testing In Primary Aldosteronism (SCIPA): A Multicenter Retrospective Diagnostic Accuracy Study'.
2. The inclusion criteria were updated.
3. The recruitment end date and overall study end date were changed from 30/07/2023 to 31/03/2024.
4. The intention to publish date was changed from 01/06/2024 to 01/07/2024.
5. Basic results uploaded.
05/09/2023: Contact details updated.
04/09/2023: Basic results uploaded.
16/08/2023: Trial's existence confirmed by St. Luke’s Institutional Ethics Review Committee (IERC)
