With a standardized approach in a population with difficult to treat hypertension we want to explore how frequenty PHA is a cause of hypertension and what the test characteristics of the aldosterone-renin ratio are. Additionally we want to…
ID
Source
Brief title
Condition
- Adrenal gland disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are 1) the test characteristic of the aldosterone-renin ratio
in a population of difficult to treat hypertensive subjects and 2) determinants
of the blood pressure response to an aldosterone receptor antagonist.
Secondary outcome
Secondary endpoints are 1) the prevalence of PHA in a Dutch population of
difficult to treat hypertension, 2) the influence of antihypertensive therapy
on the aldosterone-renin ratio and 3) the concordance between the intravenous
and oral salt loading test.
Background summary
Primary aldosteronism (PA) is characterized by an autonomous production of
aldosterone by the adrenal gand, almost always resulting in a moderate to
severe rise in blood pressure, a suppressed plasma renin activity and sometimes
hypokalemia. To establish the diagnosis of PHA is important for two reasons.
First, this condition requires specific treatment, and second it is associated
with an increased risk of cardiovascular disease as compared to essential
hypertension. Owing to the frequent use of the aldosterone-renin ratio as a
screening test, PHA appears to be an unexpected frequent cause of hypertension.
In The Netherlands systematic screening of PHA does not take place and the way
the diagnostic tests are performed in hospitals is variable.
Study objective
With a standardized approach in a population with difficult to treat
hypertension we want to explore how frequenty PHA is a cause of hypertension
and what the test characteristics of the aldosterone-renin ratio are.
Additionally we want to investigate the determinants of the aldosteron-renin
ratio and explore whether this ratio predicts the blood pressure response to an
aldosterone receptor antagonist.
Study design
In a multicentric study patients with difficult to treat hypertension undergo a
diagnostic and a therapeutic traject. In each patient the aldosterone-renin
ratio is measured two times while patients use their own antihypertensive
medication. Beta-adrenergic-receptor blocking agents and potassium-sparing
diuretics are forbidden. The ratio is repeated after the patients have been
treated with antihypertensive combination therapy that does not influence the
aldosterone-renin ratio. All patients are subjected to an intravenous (gold
standard) and oral salt loading test. subsequently patients are treated for 3
months with an aldosterone receptor antagonist added to their usual
antihypertensive medication. The blood pressure response to the
aldosterone-receptor blocker will be related to the aldosterone-renin ratio.
Intervention
Treatment for 3 months with eplerenone, 50 mg once daily.
Study burden and risks
The burden of the patients is mainly time investment (6 to 7 hours during a
study period of 38 weeks). The risk is low. All tests applied are standard
procedures. Eplerenone that is used in the therapeutic phase of the study is
registered in the Netherlands as highly selective aldosterone receptor
antagonist for the treatment of chronic cardiac failure.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Refractory hypertension
Men and women (non-pregnant)
Age 18-60 yrs
BMI < 32 kg/m2
Exclusion criteria
Known cause of hypertension
White coat hypertension
Severe renal failure
BMI >32 kg/min
Stroke or myocardial infarction within the last 6 months
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2006-006618-13-NL |
| ClinicalTrials.gov | NCT00407784 |
| CCMO | NL11725.078.06 |