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

Completed

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

In brief

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.

Key facts

Study ID

NCT04761354

Run by

UMC Utrecht

People needed

514

Starts

2016-03-26

Expected to finish

2017-03-26

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• University of Sydney — Sydney, New South Wales, Australia
• University Health Network Toronto — Toronto, Ontario, Canada
• Montreal General Hospital - McGill University — Montreal, Quebec, Canada
• Istituto di Semeiotica Chirurgica Roma — Rome, Lazio, Italy
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands
• Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands
• University Medical Center Groningen — Groningen, Netherlands

Full record on ClinicalTrials.gov

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