Unilateral adrenalectomy
ProcedureOther names: Endoscopic posterior adrenalectomy
NCT Number: NCT04761354
Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia. During the last decades the prevalence of PA has risen, predominantly due to better awareness of disease. Several studies estimated a prevalence of PA up to 17% in an unselected population of hypertensive patients. However, in a population with resistant hypertension the reported prevalence is even higher: 17-23%. This emphasizes the clinical impact of PA on morbidity and mortality due to high blood pressure. Since both hypertension and aldosteronism are independent risk factors for cardiovascular morbidity, the aim of treatment is curation or reduction of both.
After an adrenalectomy for APA normalization of biochemical abnormalities is achieved in almost all cases. Nevertheless, curation of hypertension (systolic blood pressure <140 and diastolic blood pressure <90 mmHg) without the need of antihypertensive medication is accomplished in only 35-45% of the cases. In 2008 the Aldosteronoma Resolution Score (ARS) was developed. This score predicts the likelihood of complete resolution of the hypertension in patients with an aldosteronoma and has been validated by other investigator groups.
Reduction of hypertension is also an important clinical outcome and is reported in 90-98% of the patients after surgery. In most studies reduction is defined as a certain decrease in blood pressure or antihypertensive medication. However, there is no consensus on the precise definition of reduction in these patients, which leads to incomparable results.
The aim of the proposed study is to determine the proportion of patients with clinically relevant reduction of hypertension after adrenalectomy in a large cohort. Furthermore, the investigators aim to determine the characteristics predicting this clinically relevant reduction. Additionally, the investigators evaluate the predictive value of the Aldosteronoma Resolution Score for clinically relevant reduction and aim to develop a scoring system to help clinicians predict the likelihood of reduction of hypertension after adrenalectomy so it can be used for patient counseling.
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Notify Me18 year and older
All sexes
Observational
University of Sydney, Sydney, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Endoscopic posterior adrenalectomy
Time frame: 6 months postoperative
systolic and diastolic blood pressure via office blood pressure measurements
Time frame: 6 months postoperative (corresponding to the entered postoperative blood pressure)
number of antihypertensives in defined daily dose
Time frame: 6 months postoperative
resolution of hypertension score via the PASO consensus criteria
Time frame: 6 months postoperative
Serum potassium in mmol/l.
Time frame: 6 months postoperative
Plasma aldosterone in nmol/l.
Time frame: 6 months postoperative
Plasma renin activity in mg/L/u.
Time frame: 6 months postoperative
Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity
Time frame: 6 months postoperative
Plasma creatinine in mg/dL
Time frame: 6 months postoperative
Final result of pathology after adrenalectomy
UMC Utrecht
Other
Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
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