Primary Aldosteronism Clinical Trial
Official title:
Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment
Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused
by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99%
predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal
hyperplasia (BAH). Diagnosis of PA is relevant for two reasons:
1. independent of the level of blood pressure, hypertension due to autonomous aldosterone
secretion causes more cardiovascular damage than essential hypertension;
2. PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid
receptor antagonists (MRA) in case of BAH.
Although previously presumed a rare condition (prevalence <1%), PA is now estimated to
affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as
the amount of cardiovascular damage and the available specific treatment, the question is
raised whether screening of PA should be introduced in Dutch general practice. To answer
this important question, several issues with regard to PA need to be elucidated:
1. International studies report a prevalence of PA in general practice of 6-13%.
Prevalence in the Dutch population is still unknown;
2. Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of
hypertension (mean eight years), data on characteristics of early diagnosed PA are
lacking. Proof of early cardiovascular damage would strengthen the case of screening
for PA and needs to be studied;
3. Consequently, the diagnostic delay has lead to lack of data on optimal treatment in
early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a
regimen of antihypertensive drugs is advised, and only if hypertension is refractory
for >6 months patients are referred. It is unknown if hypertension is resistant to
therapy in the initial phase of PA. If not, this would also argue for early biochemical
screening for PA, because even if blood pressure is controlled, the detrimental effect
of aldosterone itself will go on unopposed. It is therefore required to study the
response to antihypertensive drugs (not MRA) in these patients.
Rationale: Primary aldosteronism (PA) is the most frequent form of secondary hypertension.
It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which
is for more than 99% predominated by unilateral aldosterone-producing adenoma (APA) and
bilateral adrenal hyperplasia (BAH). Diagnosis of PA is relevant for two reasons: 1)
independent of the level of blood pressure, hypertension due to autonomous aldosterone
secretion causes more cardiovascular damage than essential hypertension; 2) PA requires
specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists
(MRA) in case of BAH.
Although previously presumed a rare condition (prevalence <1%), PA is now estimated to
affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as
the amount of cardiovascular damage and the available specific treatment, the question has
been raised whether screening of PA should be introduced in Dutch general practice. To
answer this important question, several issues with regard to PA need to be elucidated:
1. International studies report a prevalence of PA in general practice of 6-13%.
Prevalence in the Dutch population is still unknown;
2. Up to now, the laboratory test for screening for PA, the aldosterone/renin ratio (ARR),
is primarily used in secondary care. The relation between the ARR and outcomes in
primary care is unknown;
3. Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of
hypertension (mean eight years), data on characteristics of early diagnosed PA are
lacking. Indications of early cardiovascular damage would strengthen the case of
screening for PA and needs to be studied.
;
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02885662 -
Study of CS-3150 in Patients With Primary Aldosteronism
|
N/A | |
Withdrawn |
NCT02096939 -
Microvascular Function in Primary Aldosteronism
|
N/A | |
Recruiting |
NCT06228677 -
Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization
|
||
Recruiting |
NCT06047912 -
Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone
|
||
Recruiting |
NCT04991961 -
Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism
|
||
Recruiting |
NCT05405101 -
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
|
N/A | |
Recruiting |
NCT05501080 -
The Effect of SAAE on Ventricular Remodeling in PA Patients
|
N/A | |
Recruiting |
NCT05973604 -
Prevalence of Primary Aldosteronism in Atrial Fibrillation
|
||
Recruiting |
NCT05826080 -
Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism
|
||
Completed |
NCT04179019 -
Calcium Channel Blockade in Primary Aldosteronism
|
Phase 2 | |
Completed |
NCT03500120 -
Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism
|
||
Recruiting |
NCT04213963 -
Prospective Study on Primary Aldosteronism in Resistant Hypertension
|
||
Completed |
NCT05435703 -
Renal Cysts and Primary Aldosteronism
|
||
Recruiting |
NCT02945904 -
IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism
|
||
Enrolling by invitation |
NCT02257450 -
Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
|
N/A | |
Recruiting |
NCT05561361 -
The Effect of SAAE on Vascular Endothelial Function in PA Patients
|
||
Completed |
NCT03398785 -
Adrenal Artery Ablation Treats Primary Aldosteronism
|
Phase 3 | |
Recruiting |
NCT03224312 -
Chongqing Primary Aldosteronism Study
|
||
Recruiting |
NCT04428827 -
Outcome of Patients With Primary Aldosteronism
|
||
Completed |
NCT02756754 -
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism
|
N/A |