Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis

Study Overview
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Brief Summary
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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.

Official Title
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Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis

Conditions
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Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Conn Adenoma

Intervention / Treatment
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* Procedure: Unilateral adrenalectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| University Medical Center Utrecht<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| University Medical Center Groningen<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Vu University Medical Center Amsterdam<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| University Medical Center Maastricht<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Academic Medical Center Amsterdam<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Istituto di Semeiotica Chirurgica Roma<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| University of California San Francisco<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Northwestern Memorial Hospital<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Weill Cornell Medical Center<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Columbia University Medical Center<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| University of Chicago Medical Center<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| M.D. Anderson Cancer Center<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Boston Medical Center<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| University Health Network Toronto<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| Montreal General Hospital - McGill University<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|
| University of Sydney<br>Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma | Procedure: Unilateral adrenalectomy<br> <br> * Other names: Endoscopic posterior adrenalectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative blood pressure measurement | systolic and diastolic blood pressure via office blood pressure measurements | 6 months postoperative | 
| antihypertensive medication use | number of antihypertensives in defined daily dose | 6 months postoperative (corresponding to the entered postoperative blood pressure) | 
| resolution of hypertension | resolution of hypertension score via the PASO consensus criteria | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative serum potassium level | Serum potassium in mmol/l. | 6 months postoperative | 
| Postoperative plasma aldosterone level in lying and standing position | Plasma aldosterone in nmol/l. | 6 months postoperative | 
| Postoperative plasma renin activity in lying and standing position | Plasma renin activity in mg/L/u. | 6 months postoperative | 
| Postoperative aldosterone to renin ratio | Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity | 6 months postoperative | 
| Postoperative plasma creatinine level | Plasma creatinine in mg/dL | 6 months postoperative | 
| Pathology | Final result of pathology after adrenalectomy | 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Aldosteronism, Hyperaldosteronism, Adrenalectomy, Blood Pressure