Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
NCT ID: NCT04761354
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
514 participants
OBSERVATIONAL
2016-03-26
2017-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Is the Evolution of the Aldosterone-renin Ratio Pre- Versus Post-operative on Day 1 Following Unilateral Adrenalectomy for Primary Hyperaldosteronism Predictive of Blood Pressure Outcomes
NCT07110155
Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment
NCT01728493
Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism
NCT03174847
Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
NCT04409431
Outcome of Patients With Primary Aldosteronism
NCT04428827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
University Medical Center Utrecht
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
University Medical Center Groningen
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Vu University Medical Center Amsterdam
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
University Medical Center Maastricht
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Academic Medical Center Amsterdam
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Istituto di Semeiotica Chirurgica Roma
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
University of California San Francisco
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Northwestern Memorial Hospital
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Weill Cornell Medical Center
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Columbia University Medical Center
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
University of Chicago Medical Center
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
M.D. Anderson Cancer Center
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Boston Medical Center
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
University Health Network Toronto
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Montreal General Hospital - McGill University
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
University of Sydney
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Unilateral adrenalectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Unilateral adrenalectomy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Northwestern Memorial Hospital
OTHER
Weill Medical College of Cornell University
OTHER
Columbia University
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
UMC Utrecht
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. dr. M.R. Vriens
Professor in Endocrine and Oncological Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Menno R Vriens, MD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Gerlof D Valk, MD
Role: STUDY_DIRECTOR
UMC Utrecht
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
M.D. Anderson Cancer Center
Houston, Texas, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-196/C
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.