Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
- Conditions
- Primary Aldosteronism Due to Conn AdenomaPrimary AldosteronismPrimary Aldosteronism Due to Aldosterone Producing Adenoma
- Interventions
- Procedure: Unilateral adrenalectomy
- Registration Number
- NCT04761354
- Lead Sponsor
- UMC Utrecht
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 514
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vu University Medical Center Amsterdam Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Northwestern Memorial Hospital Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Columbia University Medical Center Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University Medical Center Maastricht Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Academic Medical Center Amsterdam Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University of California San Francisco Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University of Chicago Medical Center Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma M.D. Anderson Cancer Center Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University of Sydney Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University Medical Center Groningen Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University Health Network Toronto Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Istituto di Semeiotica Chirurgica Roma Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Boston Medical Center Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Montreal General Hospital - McGill University Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma University Medical Center Utrecht Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Weill Cornell Medical Center Unilateral adrenalectomy Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
- Primary Outcome Measures
Name Time Method Postoperative blood pressure measurement 6 months postoperative systolic and diastolic blood pressure via office blood pressure measurements
resolution of hypertension 6 months postoperative resolution of hypertension score via the PASO consensus criteria
antihypertensive medication use 6 months postoperative (corresponding to the entered postoperative blood pressure) number of antihypertensives in defined daily dose
- Secondary Outcome Measures
Name Time Method Postoperative serum potassium level 6 months postoperative Serum potassium in mmol/l.
Postoperative aldosterone to renin ratio 6 months postoperative Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity
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.
Postoperative plasma creatinine level 6 months postoperative Plasma creatinine in mg/dL
Pathology 6 months postoperative Final result of pathology after adrenalectomy
Trial Locations
- Locations (14)
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University Health Network Toronto
🇨🇦Toronto, Ontario, Canada
Amsterdam University Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Montreal General Hospital - McGill University
🇨🇦Montréal, Quebec, Canada
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Sydney
🇦🇺Sydney, New South Wales, Australia
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Istituto di Semeiotica Chirurgica Roma
🇮🇹Rome, Lazio, Italy
Weill Cornell Medical College
🇺🇸New York, New York, United States