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

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.

Conditions

• Primary Aldosteronism Due to Aldosterone Producing Adenoma
• Primary Aldosteronism
• Primary Aldosteronism Due to Conn Adenoma

Interventions

PROCEDURE

Unilateral adrenalectomy

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Northwestern Memorial Hospital

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Boston Medical Center

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Montreal General Hospital

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• UMC Utrecht

  lead OTHER

Principal Investigators

• Menno R Vriens, MD · UMC Utrecht

• Gerlof D Valk, MD · UMC Utrecht

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-26

Primary Completion

2017-03-26

Completion

2017-03-26

Countries

• United States
• Australia
• Canada
• Italy
• Netherlands

Study Locations