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NCT Number: NCT04761354

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Sydney, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unilateral adrenalectomy

Procedure

Other names: Endoscopic posterior adrenalectomy

Primary outcomes

  1. Postoperative blood pressure measurement

    Time frame: 6 months postoperative

    systolic and diastolic blood pressure via office blood pressure measurements

  2. antihypertensive medication use

    Time frame: 6 months postoperative (corresponding to the entered postoperative blood pressure)

    number of antihypertensives in defined daily dose

  3. resolution of hypertension

    Time frame: 6 months postoperative

    resolution of hypertension score via the PASO consensus criteria

Secondary outcomes

  1. Postoperative serum potassium level

    Time frame: 6 months postoperative

    Serum potassium in mmol/l.

  2. Postoperative plasma aldosterone level in lying and standing position

    Time frame: 6 months postoperative

    Plasma aldosterone in nmol/l.

  3. Postoperative plasma renin activity in lying and standing position

    Time frame: 6 months postoperative

    Plasma renin activity in mg/L/u.

  4. Postoperative aldosterone to renin ratio

    Time frame: 6 months postoperative

    Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity

  5. Postoperative plasma creatinine level

    Time frame: 6 months postoperative

    Plasma creatinine in mg/dL

  6. Pathology

    Time frame: 6 months postoperative

    Final result of pathology after adrenalectomy

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amsterdam UMC, location VUmc
  • Boston Medical Center
  • Catholic University of the Sacred Heart
  • Columbia University
  • M.D. Anderson Cancer Center
  • Maastricht University Medical Center
  • Montreal General Hospital
  • Northwestern Memorial Hospital
  • University Health Network, Toronto
  • University Medical Center Groningen
  • University of California, San Francisco
  • University of Chicago
  • University of Sydney
  • Weill Medical College of Cornell University

Registry information

Official study title

Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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