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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Northwestern Memorial Hospital | OTHER |
| Weill Medical College of Cornell University | OTHER |
| Columbia University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| University Medical Center Utrecht | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| |
| University Medical Center Groningen | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| |
| Vu University Medical Center Amsterdam | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| |
| University Medical Center Maastricht | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| |
| Academic Medical Center Amsterdam | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| |
| Istituto di Semeiotica Chirurgica Roma |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral adrenalectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative serum potassium level | Serum potassium in mmol/l. | 6 months postoperative |
| Postoperative plasma aldosterone level in lying and standing position | Plasma aldosterone in nmol/l. |
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Inclusion Criteria:
Exclusion Criteria:
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Primary aldosteronism patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA
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| Name | Affiliation | Role |
|---|---|---|
| Menno R Vriens, MD | UMC Utrecht | Principal Investigator |
| Gerlof D Valk, MD | UMC Utrecht | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Northwestern Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28576687 | Background | 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. | |
| 18376197 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2016 |
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| OTHER |
| University of Chicago | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Boston Medical Center | OTHER |
| University Health Network, Toronto | OTHER |
| Montreal General Hospital | OTHER |
| University of Sydney | OTHER |
| University Medical Center Groningen | OTHER |
| Maastricht University Medical Center | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Catholic University of the Sacred Heart | OTHER |
| Amsterdam UMC, location VUmc | OTHER |
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Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| University of California San Francisco | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| Northwestern Memorial Hospital | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| Weill Cornell Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| Columbia University Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| University of Chicago Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| M.D. Anderson Cancer Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| Boston Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| University Health Network Toronto | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| Montreal General Hospital - McGill University | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
| University of Sydney | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
|
|
| 6 months postoperative |
| Postoperative plasma renin activity in lying and standing position | Plasma renin activity in mg/L/u. | 6 months postoperative |
| Postoperative aldosterone to renin ratio | Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity | 6 months postoperative |
| Postoperative plasma creatinine level | Plasma creatinine in mg/dL | 6 months postoperative |
| Pathology | Final result of pathology after adrenalectomy | 6 months postoperative |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Sydney | Sydney | New South Wales | Australia |
| University Health Network Toronto | Toronto | Ontario | Canada |
| Montreal General Hospital - McGill University | Montreal | Quebec | Canada |
| Istituto di Semeiotica Chirurgica Roma | Rome | Lazio | Italy |
| Maastricht University Medical Center | Maastricht | Limburg | Netherlands |
| Amsterdam University Medical Center | Amsterdam | North Holland | Netherlands |
| University Medical Center Groningen | Groningen | Netherlands |
| Background |
| 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. |
| 22000827 | Background | 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. |
| 25456916 | Background | 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. |
| 14597859 | Background | 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. |
| 30810749 | Result | 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. |
| 31053245 | Result | 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. |
| 31270571 | Result | 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. |
| 32025781 | Result | 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. |
| Feb 10, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D018246 | Adrenocortical Adenoma |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000303 | Adrenal Cortex Diseases |
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