In this study we want to investigate long-term follow-up of patients with PA. The outcome will be analyzed based on whether a decision to treat was guided by CT/MRI or AVS or both.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Course of blood pressure, medication and laboratory results after operation or
after start of PA specific medication (in the non-operated patients)
Secondary outcome
Differences in outcome based on whether a decision to treat was guided by
CT/MRI or AVS or both. Differences in outcome between operated and non-operated
patients.
Background summary
Primary aldosteronism (PA) is considered a frequent cause of hypertension. In
PA hypertension is often found to be refractory to common antihypertensive
drugs. Surgery has the potential to cure the disease with normalization of
blood pressure without medication. However an adrenalectomy is only indicated
in case of unilateral adrenal pathology; patients with bilateral adrenal
pathology need to be treated medically. Therefore, an accurate distinction
between the unilateral and bilateral type of PA is of utmost importance.
Differentiation between both forms is usually done using imaging techniques
such as CT/MRI or by means of adrenal venous sampling (AVS). However, results
of CT/MRI and AVS are discordant in 41% of patients; e.g. unilateral pathology
shown by CT/MRI whereas AVS indicates bilateral pathology, or vice versa, or
unilateral pathology shown by CT/MRI whereas AVS indicates that the
contralateral adrenal gland is affected. In general AVS is considered to be the
gold standard to accurately differentiate between unilateral and bilateral
adrenal pathology in PA and consequently, to accurately identify patients
eligible for adrenalectomy or medical treatment. However, only detailed
knowledge on long-term follow up results, in terms of severity of hypertension,
use of medication(s) and improvement of biochemical parameters, can identify
whether the decision to treat a patiƫnt with adrenalectomy has been legitimate.
To date, such detailed long-term follow up results are not available.
Study objective
In this study we want to investigate long-term follow-up of patients with PA.
The outcome will be analyzed based on whether a decision to treat was guided by
CT/MRI or AVS or both.
Study design
Of all patients with PA, known in the UMCN St. Radboud, the medical file will
be examined to gather medical data. The patients who underwent an adrenalectomy
will be invited for a visit to the UMCN St. Radboud. During this visit
standardized blood pressure measurements will be done and a venapuncture will
be done to determine aldosterone, renin, potassium and creatinin.
Study burden and risks
For the operated patients who are not visiting the UMCN St. Radboud anymore,
participation involves an extra visit to our hospital. There are no risks for
the participating patients.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Patients with primary aldosteronism known in the UMCN St. Radboud in whom CT and/or MRI and/or AVS have been performed
Exclusion criteria
geen
Design
Recruitment
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 |
---|---|
CCMO | NL21121.091.07 |