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

UMC Utrecht

Status: Completed

Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Conn Adenoma; Primary Aldosteronism

Treatments: Procedure: Unilateral adrenalectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04761354

16-196/C

Details and patient eligibility

About

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.

Enrollment: 514 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

514 participants in 16 patient groups

University Medical Center Utrecht

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

University Medical Center Groningen

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Vu University Medical Center Amsterdam

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

University Medical Center Maastricht

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Academic Medical Center Amsterdam

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Istituto di Semeiotica Chirurgica Roma

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

University of California San Francisco

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Northwestern Memorial Hospital

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Weill Cornell Medical Center

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Columbia University Medical Center

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

University of Chicago Medical Center

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

M.D. Anderson Cancer Center

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Boston Medical Center

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

University Health Network Toronto

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

Montreal General Hospital - McGill University

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy

University of Sydney

Description:

Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma

Treatment:

Procedure: Unilateral adrenalectomy