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

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byMenno R Vriens, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: UMC Utrecht

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Menno R Vriens, MD

Principal Investigator

UMC Utrecht

Gerlof D Valk, MD

Principal Investigator

UMC Utrecht

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).

Treatment Details

Interventions

Unilateral adrenalectomy (Procedure)

Participant Groups

16Treatment groups

Experimental Treatment

Group I: Weill Cornell Medical CenterExperimental Treatment1 Intervention