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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04761354




Registration number
NCT04761354
Ethics application status
Date submitted
10/02/2021
Date registered
18/02/2021
Date last updated
18/02/2021

Titles & IDs
Public title
Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
Scientific title
Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
Secondary ID [1] 0 0
16-196/C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Aldosteronism Due to Aldosterone Producing Adenoma 0 0
Primary Aldosteronism 0 0
Primary Aldosteronism Due to Conn Adenoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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 - 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Postoperative blood pressure measurement
Timepoint [1] 0 0
6 months postoperative
Primary outcome [2] 0 0
antihypertensive medication use
Timepoint [2] 0 0
6 months postoperative (corresponding to the entered postoperative blood pressure)
Primary outcome [3] 0 0
resolution of hypertension
Timepoint [3] 0 0
6 months postoperative
Secondary outcome [1] 0 0
Postoperative serum potassium level
Timepoint [1] 0 0
6 months postoperative
Secondary outcome [2] 0 0
Postoperative plasma aldosterone level in lying and standing position
Timepoint [2] 0 0
6 months postoperative
Secondary outcome [3] 0 0
Postoperative plasma renin activity in lying and standing position
Timepoint [3] 0 0
6 months postoperative
Secondary outcome [4] 0 0
Postoperative aldosterone to renin ratio
Timepoint [4] 0 0
6 months postoperative
Secondary outcome [5] 0 0
Postoperative plasma creatinine level
Timepoint [5] 0 0
6 months postoperative
Secondary outcome [6] 0 0
Pathology
Timepoint [6] 0 0
6 months postoperative

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2017
Sample size
Target
Accrual to date
Final
514
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Italy
State/province [8] 0 0
Lazio
Country [9] 0 0
Netherlands
State/province [9] 0 0
Limburg
Country [10] 0 0
Netherlands
State/province [10] 0 0
Noord-Holland
Country [11] 0 0
Netherlands
State/province [11] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Other
Name
UMC Utrecht
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of California, San Francisco
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northwestern Memorial Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Weill Medical College of Cornell University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Columbia University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Chicago
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
M.D. Anderson Cancer Center
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Boston Medical Center
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University Health Network, Toronto
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Montreal General Hospital
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
University of Sydney
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University Medical Center Groningen
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Maastricht University Medical Center
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Catholic University of the Sacred Heart
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Amsterdam UMC, location VUmc
Address [15] 0 0
Country [15] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04761354
Trial related presentations / publications
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. Erratum In: World J Surg. 2020 Jan;44(1):323. doi: 10.1007/s00268-019-05150-4.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Menno R Vriens, MD
Address 0 0
UMC Utrecht
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04761354