Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Conn Adenoma
Conditions
Keywords
Primary Aldosteronism, Hyperaldosteronism, Adrenalectomy, Blood Pressure
Brief summary
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.
Interventions
PROCEDUREUnilateral adrenalectomy
Sponsors
University of California, San Francisco
Northwestern Memorial Hospital
Weill Medical College of Cornell University
Columbia University
University of Chicago
M.D. Anderson Cancer Center
Boston Medical Center
University Health Network, Toronto
Montreal General Hospital
University of Sydney
University Medical Center Groningen
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Catholic University of the Sacred Heart
Amsterdam UMC, location VUmc
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA. * Patients with biochemical evidence of primary aldosteronism who underwent adrenalectomy on account of an aldosterone-producing adenoma(APA), proven by Computerized Tomography(CT) or Magnetic Resonance Imaging(MRI) or Adrenal Venous Sampling(AVS).
Exclusion criteria
* Age \<18 years. * Missing or incomplete data about preoperative blood pressure and number of antihypertensive drugs. * Missing or incomplete follow-up data about postoperative blood pressure and number of antihypertensive drugs. We aim enter the blood pressure and number of antihypertensive drugs closest to 6 months after adrenalectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative blood pressure measurement | 6 months postoperative | systolic and diastolic blood pressure via office blood pressure measurements |
| antihypertensive medication use | 6 months postoperative (corresponding to the entered postoperative blood pressure) | number of antihypertensives in defined daily dose |
| resolution of hypertension | 6 months postoperative | resolution of hypertension score via the PASO consensus criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative aldosterone to renin ratio | 6 months postoperative | Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity |
| Postoperative serum potassium level | 6 months postoperative | Serum potassium in mmol/l. |
| Pathology | 6 months postoperative | Final result of pathology after adrenalectomy |
| Postoperative plasma creatinine level | 6 months postoperative | Plasma creatinine in mg/dL |
| Postoperative plasma aldosterone level in lying and standing position | 6 months postoperative | Plasma aldosterone in nmol/l. |
| Postoperative plasma renin activity in lying and standing position | 6 months postoperative | Plasma renin activity in mg/L/u. |
Countries
Australia, Canada, Italy, Netherlands, United States
Outcome results
None listed