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

NCT ID: NCT04761354

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

514 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-26

Study Completion Date

2017-03-26

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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University Medical Center Utrecht

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

University Medical Center Groningen

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Vu University Medical Center Amsterdam

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

University Medical Center Maastricht

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Academic Medical Center Amsterdam

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Istituto di Semeiotica Chirurgica Roma

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

University of California San Francisco

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Northwestern Memorial Hospital

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Weill Cornell Medical Center

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Columbia University Medical Center

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

University of Chicago Medical Center

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

M.D. Anderson Cancer Center

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Boston Medical Center

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

University Health Network Toronto

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Montreal General Hospital - McGill University

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

University of Sydney

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

Unilateral adrenalectomy

Intervention Type PROCEDURE

Interventions

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Unilateral adrenalectomy

Intervention Type PROCEDURE

Other Intervention Names

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Endoscopic posterior adrenalectomy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Northwestern Memorial Hospital

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Montreal General Hospital

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. M.R. Vriens

Professor in Endocrine and Oncological Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Menno R Vriens, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Gerlof D Valk, MD

Role: STUDY_DIRECTOR

UMC Utrecht

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Sydney

Sydney, New South Wales, Australia

Site Status

University Health Network Toronto

Toronto, Ontario, Canada

Site Status

Montreal General Hospital - McGill University

Montreal, Quebec, Canada

Site Status

Istituto di Semeiotica Chirurgica Roma

Rome, Lazio, Italy

Site Status

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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United States Australia Canada Italy Netherlands

References

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Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.

Reference Type BACKGROUND
PMID: 28576687 (View on PubMed)

Zarnegar R, Young WF Jr, Lee J, Sweet MP, Kebebew E, Farley DR, Thompson GB, Grant CS, Clark OH, Duh QY. The aldosteronoma resolution score: predicting complete resolution of hypertension after adrenalectomy for aldosteronoma. Ann Surg. 2008 Mar;247(3):511-8. doi: 10.1097/SLA.0b013e318165c075.

Reference Type BACKGROUND
PMID: 18376197 (View on PubMed)

Utsumi T, Kawamura K, Imamoto T, Kamiya N, Komiya A, Suzuki S, Nagano H, Tanaka T, Nihei N, Naya Y, Suzuki H, Tatsuno I, Ichikawa T. High predictive accuracy of Aldosteronoma Resolution Score in Japanese patients with aldosterone-producing adenoma. Surgery. 2012 Mar;151(3):437-43. doi: 10.1016/j.surg.2011.08.001. Epub 2011 Oct 13.

Reference Type BACKGROUND
PMID: 22000827 (View on PubMed)

Aronova A, Gordon BL, Finnerty BM, Zarnegar R, Fahey TJ 3rd. Aldosteronoma resolution score predicts long-term resolution of hypertension. Surgery. 2014 Dec;156(6):1387-92; discussion 1392-3. doi: 10.1016/j.surg.2014.08.019. Epub 2014 Nov 11.

Reference Type BACKGROUND
PMID: 25456916 (View on PubMed)

Stowasser M, Gordon RD, Gunasekera TG, Cowley DC, Ward G, Archibald C, Smithers BM. High rate of detection of primary aldosteronism, including surgically treatable forms, after 'non-selective' screening of hypertensive patients. J Hypertens. 2003 Nov;21(11):2149-57. doi: 10.1097/00004872-200311000-00025.

Reference Type BACKGROUND
PMID: 14597859 (View on PubMed)

Vorselaars WMCM, Nell S, Postma EL, Zarnegar R, Drake FT, Duh QY, Talutis SD, McAneny DB, McManus C, Lee JA, Grant SB, Grogan RH, Romero Arenas MA, Perrier ND, Peipert BJ, Mongelli MN, Castelino T, Mitmaker EJ, Parente DN, Pasternak JD, Engelsman AF, Sywak M, D'Amato G, Raffaelli M, Schuermans V, Bouvy ND, Eker HH, Bonjer HJ, Vaarzon Morel NM, Nieveen van Dijkum EJM, Vrielink OM, Kruijff S, Spiering W, Borel Rinkes IHM, Valk GD, Vriens MR; International CONNsortium study group. Clinical Outcomes After Unilateral Adrenalectomy for Primary Aldosteronism. JAMA Surg. 2019 Apr 1;154(4):e185842. doi: 10.1001/jamasurg.2018.5842. Epub 2019 Apr 17.

Reference Type RESULT
PMID: 30810749 (View on PubMed)

Vorselaars WMCM, van Beek DJ, Postma EL, Spiering W, Borel Rinkes IHM, Valk GD, Vriens MR; International CONNsortium study group. Clinical outcomes after surgery for primary aldosteronism: Evaluation of the PASO-investigators' consensus criteria within a worldwide cohort of patients. Surgery. 2019 Jul;166(1):61-68. doi: 10.1016/j.surg.2019.01.031. Epub 2019 May 1.

Reference Type RESULT
PMID: 31053245 (View on PubMed)

Vorselaars WMCM, van Beek DJ, Postma EL, Spiering W, Borel Rinkes IHM, Valk GD, Vriens MR; International CONNsortium Study Group. Validation of the Aldosteronoma Resolution Score Within Current Clinical Practice. World J Surg. 2019 Oct;43(10):2459-2468. doi: 10.1007/s00268-019-05074-z.

Reference Type RESULT
PMID: 31270571 (View on PubMed)

Vorselaars WMCM, van Beek DJ, Suurd DPD, Postma E, Spiering W, Borel Rinkes IHM, Valk GD, Vriens MR; International CONNsortium*. Adrenalectomy for Primary Aldosteronism: Significant Variability in Work-Up Strategies and Low Guideline Adherence in Worldwide Daily Clinical Practice. World J Surg. 2020 Jun;44(6):1905-1915. doi: 10.1007/s00268-020-05408-2.

Reference Type RESULT
PMID: 32025781 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-196/C

Identifier Type: -

Identifier Source: org_study_id

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