Assessment of reference values in plasma of renin and aldosterone and in 24h urinary of aldosterone (Aldo-18G and TH-Aldo) before and after a 3-day oral salt loading test , respectively. In addition, establishing assay specific conversion factors…
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>95% confidence intervals of renine and aldosterone before and after a 3-day oral salt loading test.</p>
Secondary outcome
<p>conversion factors between the assays for determination of renin and aldosterone</p>
Background summary
Primary aldosteronism (PA) is the most frequent cause of hypertension. It is associated with a high cardiovascular risk and requires a specific treatment depending on the PA subtype. The biochemical diagnosis of PA is a two-step process, i.e. screening by assessment of the aldosterone-renin ratio in plasma, followed by confirmation through performance of a salt loading protocol with assessment of the suppressibility of the aldosterone secretion. A correct interpretation of the renin and aldosterone levels during these tests is highly dependent on the characteristics of the applied hormone assays, as each specific assay has its own reference range and cut-off values. Establishing reference values is no easy task and despite the obvious shortcomings, most laboratories cite reference values that are either described in the assay package insert or reported in the literature
Study objective
Assessment of reference values in plasma of renin and aldosterone and in 24h urinary of aldosterone (Aldo-18G and TH-Aldo) before and after a 3-day oral salt loading test , respectively. In addition, establishing assay specific conversion factors between the assays for determination of renin and aldosterone used in the UMCG and the various other assays available in The Netherlands
Study design
Intervention study subjecting health volunteers to a 3-day oral salt loading test
Intervention
response of renin and aldosterone to salt loading
Study burden and risks
This is a study with a short duration of 5 days, including 2 outpatient visits and a 3-day oral salt loading test performed at home. Risks are negligible and are associated with the very low risks of a venipuncture (pain, hematoma, vasovagal collapse). Study subjects will not benefit directly from their participation.The screening laboratory tests might reveal the presence of hyperglycemia or an abnormal renal or liver function. In that case, the participant might benefit from an early diagnosis. The study will provide assay-specific reference ranges for renin and aldosterone, as determined in normotensive subjects. This will contribute to improve the diagnostic accuracy of testing for PA among hypertensive subjects.
MN Kerstens
Hanzeplein 1
Groningen 9713 GZ
Netherlands
+31-50-3616161
m.n.kerstens@umcg.nl
MN Kerstens
Hanzeplein 1
Groningen 9713 GZ
Netherlands
+31-50-3616161
m.n.kerstens@umcg.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- healthy male and female subjects
- normal blood pressure, i.e. office systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg
Exclusion criteria
- hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
- past medical history of heart failure, myocardial infarction, stroke, TIA, peripheral arterial disease or adrenal gland disorder
- elevated liver enzymes (ALAT/ASAT/gammaGT/AF > 1.5 times URL)
- renal insufficiency (eGFR < 60 mL/min/1.73m2 )
- diabetes mellitus (any type)
- pregnancy
- use of one of the following drugs: ACE- inhibitors,angiotensin receptor blockers, renin blockers, calcium channel blockers, diuretics, betablockers, alphablockers, centrally acting antihypertensives (like clonidine, moxonidine, methyldopa), nonsteroidal anti-inflammatory drugs, potassium supplements, oral contraceptives, sex hormone replacement therapy, glycyrrhizin containing products
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
The assay specific reference ranges for renin an aldosterone will improve the diagnosis of primary aldosteronism.
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Research portal | NL-009466 |