Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05232162 |
| Other study ID # |
ARR reference range |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2021 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
January 2022 |
| Source |
University Malaysia Sarawak |
| Contact |
Huai Heng H Loh |
| Phone |
0122010765 |
| Email |
hhloh[@]unimas.my |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Elevated aldosterone levels were also shown to contribute to the excess morbidity and
mortality. Literature shows aldosterone and renin levels differ between ethnicity and gender.
There is no established reference intervals for these two hormone levels in Asian community.
We aim to establish reference intervals for plasma aldosterone and direct renin
concentrations among Malaysians residing in Sarawak using the chemiluminescent immunoassay
(CLIA).
This is a cross-sectional study which will be conducted among ambulatory patients, healthy
blood donors and healthy volunteers. 300 participants who fulfil study criteria will be
recruited after informed consent.
Socio-demographic data and anthropometric measurements will be recorded. Blood will be taken
for plasma aldosterone, renin, serum potassium and creatinine. Urine will be collected for
estimation of 24-hour sodium excretion. Aldosterone and renin reference intervals will be
established partitioned for gender.
Description:
Despite old beliefs that Primary Aldosteronism (PA) is uncommon and warrants screening only
when patients present with hypertension and hypokalemia, it is now believed that PA is in
fact the most common cause of secondary hypertension, accounting for 5-13% of the
hypertensive cohort, with an even higher prevalence among those with resistant hypertension.
This stems from more efficient screening of this condition with the widespread use of the
aldosterone to renin ratio. It is a disorder in which the adrenal cortex autonomously
produces excessive aldosterone leading to sodium and water retention, resulting in a
subsequent rise of blood pressure (BP), and down-regulation of renin through the
renin-angiotensin-aldosterone system (RAAS) pathway.
Once considered a relatively benign condition, PA has been unequivocally shown to have
effects beyond its effects on BP levels. Hypertension alone could not explain the higher
adverse cardiovascular outcomes as PA patients were found to have higher cardiovascular
mortality compared to patients with essential hypertension (EH) despite being matched for
cardiovascular risks.
Elevated aldosterone levels were also shown to contribute to the excess morbidity and
mortality. Recent studies have shown that PA is associated with a myriad of other
co-morbidities, particularly cardiovascular and renal injuries, which might play a role in
contributing to the elevated morbidity and mortality.
Traditionally, the activity of renin-angiotensin-aldosterone system is evaluated by
measurement of plasma renin activity (PRA). However, PRA measurement is a complex procedure
with poor inter-laboratory reproducibility, which makes it a limitation preventing more
extensive use of PRA for diagnostic purposes. Direct renin assay is a new chemiluminescent
renin assay, which utilizes the high specificity of monoclonal antibodies to detect the renin
molecule, and is proven as a good alternative to the use of PRA. The use of this new assay
appears to be simpler, faster and more reproducible than PRA, which is shown in a recent
multi-center comparative study.
Literature shows aldosterone and renin levels differ between ethnicity and gender. There is
no established reference intervals for these two hormone levels in Asian community.
General objective:
To establish reference intervals for plasma aldosterone and direct renin concentrations among
Asians in the Sarawak population using the chemiluminescent immunoassay (CLIA).
Specific objective:
To compare reference ranges among gender.
This is a cross-sectional study which will be conducted among ambulatory patients, healthy
blood donors and healthy volunteers. Participants who fulfil study criteria will be recruited
after informed consent.
The inclusion criteria are subjects who are:
1. aged 18 years old and above
2. agreeable to participate in this study
3. Malaysian
4. normal kidney function (eGFR>60ml/min/1.73m2)
5. BMI<27.5kg/m2
Whereas exclusion criteria are subjects who are
1. taking prescribed/OTC medications within 3 months of study
2. taking estrogen, either oral contraceptive pills or hormone replacement therapy
3. having hypertension defined as systolic blood pressure>140 and/or diastolic blood
pressure>90mmHg or on anti-hypertensive
4. pregnant
5. smokers
Socio-demographic data on age, gender, ethnicity, body mass index (BMI), medication usage,
smoking and pregnancy status will be recorded. Seated blood pressure will be measured using
appropriately-sized cuff after 5 minutes of rest. The mean of 2 readings will be recorded.
A total of 10ml of whole blood will be withdrawn after the subjects have been seated for at
least 15 minutes, between 8am and 10am. Blood drawn will be collected into appropriate
specimen tubes - potassium EDTA tubes for plasma aldosterone and plasma renin; plain tubes
for measurement of serum potassium and creatinine. Urine will be collected for estimation of
24-hour sodium excretion.
Specimen tubes will be kept at room temperature and transported within 30 minutes of blood
drawn to the laboratory for immediate processing (centrifugation, separation and freezing of
plasma). Plasma will be stored in a temperature-controlled freezer at -20C for a maximum of
six months prior to analysis on the Liaison instrument. Measurements of plasma aldosterone
will be performed using chemiluminescent immunoassay (CLIA) aldosterone kit (DiaSorin S.p.A.,
Italy), with inter-assay and intra-assay coefficient variations (CV) of less than 10% and
4.2% respectively. Measurements of plasma renin will be done using chemiluminescent
immunoassay (CLIA) renin kit (DiaSorin S.p.A., Italy). Serum potassium and creatinine will be
processed within 2 hours of blood draw. The samples will be stored for a maximum of two weeks
prior to analysis. The eGFR will be calculated using the Modification of Diet in Renal
Disease (MDRD) Study equation. Urine will be stored for a maximum of two weeks prior to
analysis for urine sodium, potassium and creatinine. Sodium excretion will be calculated
using INTERSALT formula.
The participation duration for each participant is 30 minutes.
Withdrawal criteria Participants can choose to withdraw at any time after informed consent.
Participants may be withdrawn if the investigator deems that it is unsuitable for the
participants to be involved in this study. Withdrawn participants will be replaced until
sample size is adequate.
Sample size We aim to recruit 300 participants (150 males and 150 females) for the purpose of
establishing the reference interval of aldosterone and renin among Malaysians residing in
Sarawak.
