Clinical trial NCT04761354: Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
Official title: Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism
Primary Aldosteronism Due to Conn Adenoma
Keywords: Primary Aldosteronism
Hyperaldosteronism
Adrenalectomy
Blood Pressure
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Northwestern Memorial Hospital
name: Weill Medical College of Cornell University
name: Columbia University
name: University of Chicago
name: M.D. Anderson Cancer Center
name: Boston Medical Center
name: University Health Network, Toronto
name: Montreal General Hospital
name: University of Sydney
name: University Medical Center Groningen
name: Maastricht University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Catholic University of the Sacred Heart
name: Amsterdam UMC, location VUmc
First posted: 2021-02-18
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary aldosteronism patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative blood pressure measurement
timeFrame: 6 months postoperative
measure: antihypertensive medication use
timeFrame: 6 months postoperative (corresponding to the entered postoperative blood pressure)
measure: resolution of hypertension
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Postoperative serum potassium level
timeFrame: 6 months postoperative
measure: Postoperative plasma aldosterone level in lying and standing position
timeFrame: 6 months postoperative
measure: Postoperative plasma renin activity in lying and standing position
timeFrame: 6 months postoperative
measure: Postoperative aldosterone to renin ratio
timeFrame: 6 months postoperative
measure: Postoperative plasma creatinine level
timeFrame: 6 months postoperative
measure: Pathology
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
city: Toronto
country: Canada
facility: University Health Network Toronto
state: Ontario
city: Montréal
country: Canada
facility: Montreal General Hospital - McGill University
state: Quebec
city: Rome
country: Italy
facility: Istituto di Semeiotica Chirurgica Roma
state: Lazio
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noord-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMC Utrecht
name: Menno R Vriens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Gerlof D Valk, MD
role: STUDY_DIRECTOR
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