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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

514

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach

5 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

March 26, 2016

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2017

Completed

3.9 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed

Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 10, 2021

Last Update Submit

February 17, 2021

Conditions

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

Keywords

Primary AldosteronismHyperaldosteronismAdrenalectomyBlood Pressure

Outcome Measures

Primary Outcomes (3)

Postoperative blood pressure measurement
systolic and diastolic blood pressure via office blood pressure measurements
6 months postoperative
antihypertensive medication use
number of antihypertensives in defined daily dose
6 months postoperative (corresponding to the entered postoperative blood pressure)
resolution of hypertension
resolution of hypertension score via the PASO consensus criteria
6 months postoperative