Primary Aldosteronism Due to Aldosterone Producing AdenomaNCT04761354
Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
An observational study of Primary Aldosteronism Due to Aldosterone Producing Adenoma and Primary Aldosteronism, run by UMC Utrecht at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism, Primary Aldosteronism Due to Conn Adenoma
- What is being tested?
- Unilateral adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 514 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 26 Mar 2016to 26 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary aldosteronism patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States7 sites
Boston Medical Center
Boston, Massachusetts, 02118
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
M.D. Anderson Cancer Center
Houston, Texas, 77030
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
University of California San Francisco
San Francisco, California, 94143
Netherlands3 sites
Amsterdam University Medical Center
Amsterdam, North Holland
University Medical Center Groningen
Groningen
Maastricht University Medical Center
Maastricht, Limburg
Canada2 sites
Montreal General Hospital - McGill University
Montreal, Quebec
University Health Network Toronto
Toronto, Ontario
About this study
Official title: Characteristics Predicting Clinically Relevant Reduction of Hypertension Following 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.
Read more
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.
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism, Primary Aldosteronism Due to Conn Adenoma
- Being tested
- Unilateral adrenalectomy
- Keywords
- Primary Aldosteronism, Hyperaldosteronism, Adrenalectomy, Blood Pressure
- Medical subject headings
- Hyperaldosteronism, Adrenocortical Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral adrenalectomyProcedure or surgery
Also called Endoscopic posterior adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| University Medical Center Utrecht | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| University Medical Center Groningen | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Vu University Medical Center Amsterdam | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| University Medical Center Maastricht | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Academic Medical Center Amsterdam | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Istituto di Semeiotica Chirurgica Roma | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| University of California San Francisco | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Northwestern Memorial Hospital | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Weill Cornell Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Columbia University Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| University of Chicago Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| M.D. Anderson Cancer Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Boston Medical Center | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| University Health Network Toronto | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| Montreal General Hospital - McGill University | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy | |
| University of Sydney | Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma Receives: Procedure: Unilateral adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood pressure measurement
systolic and diastolic blood pressure via office blood pressure measurements
Measured: 6 months postoperative
antihypertensive medication use
number of antihypertensives in defined daily dose
Measured: 6 months postoperative (corresponding to the entered postoperative blood pressure)
resolution of hypertension
resolution of hypertension score via the PASO consensus criteria
Measured: 6 months postoperative
Secondary outcomes (6)
Postoperative serum potassium level
Serum potassium in mmol/l.
Measured: 6 months postoperative
Postoperative plasma aldosterone level in lying and standing position
Plasma aldosterone in nmol/l.
Measured: 6 months postoperative
Postoperative plasma renin activity in lying and standing position
Plasma renin activity in mg/L/u.
Measured: 6 months postoperative
Postoperative aldosterone to renin ratio
Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity
Measured: 6 months postoperative
Postoperative plasma creatinine level
Plasma creatinine in mg/dL
Measured: 6 months postoperative
Pathology
Final result of pathology after adrenalectomy
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start26 Mar 2016
- Primary completion26 Mar 2017
- Study completion26 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Primary Aldosteronism Due to Aldosterone Producing AdenomaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Northwestern Memorial Hospital, Weill Medical College of Cornell University, Columbia University, University of Chicago, M.D. Anderson Cancer Center, Boston Medical Center, University Health Network, Toronto, Montreal General Hospital, University of Sydney, University Medical Center Groningen, Maastricht University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catholic University of the Sacred Heart, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Prof. dr. M.R. Vriens, UMC Utrecht
- Investigators
- Menno R Vriens, MD, Principal investigator, UMC UtrechtGerlof D Valk, MD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761354
- Sponsor's protocol ID
- 16-196/C
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28576687Zarnegar 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.
PubMed 18376197Utsumi 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.
PubMed 22000827Aronova 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.
PubMed 25456916Stowasser 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.
PubMed 14597859Vorselaars 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.
PubMed 30810749Vorselaars 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.
PubMed 31053245Vorselaars 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.
PubMed 31270571Vorselaars 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.
PubMed 32025781
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
- ClinicalTrials.gov ID
- NCT04761354
- Acronym / sponsor ID
- 16-196/C
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism, Primary Aldosteronism Due to Conn Adenoma
- Keywords
- Primary Aldosteronism, Hyperaldosteronism, Adrenalectomy, Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Northwestern Memorial Hospital, Weill Medical College of Cornell University, Columbia University, University of Chicago, M.D. Anderson Cancer Center, Boston Medical Center, University Health Network, Toronto, Montreal General Hospital, University of Sydney, University Medical Center Groningen, Maastricht University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catholic University of the Sacred Heart, Amsterdam UMC, location VUmc
- Study start
- 26 Mar 2016 (actual)
- Primary completion
- 26 Mar 2017 (actual)
- Study completion
- 26 Mar 2017 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| University Medical Center Utrecht | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| University Medical Center Groningen | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Vu University Medical Center Amsterdam | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| University Medical Center Maastricht | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Academic Medical Center Amsterdam | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Istituto di Semeiotica Chirurgica Roma | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| University of California San Francisco | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Northwestern Memorial Hospital | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Weill Cornell Medical Center | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Columbia University Medical Center | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| University of Chicago Medical Center | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| M.D. Anderson Cancer Center | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Boston Medical Center | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| University Health Network Toronto | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| Montreal General Hospital - McGill University | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
| University of Sydney | – | Procedure: Unilateral adrenalectomyPatients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary aldosteronism patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral adrenalectomyAlso: Endoscopic posterior adrenalectomy | Procedure or surgery | Academic Medical Center Amsterdam, Boston Medical Center, Columbia University Medical Center, Istituto di Semeiotica Chirurgica Roma, M.D. Anderson Cancer Center, Montreal General Hospital - McGill University, Northwestern Memorial Hospital, University Health Network Toronto, University Medical Center Groningen, University Medical Center Maastricht, University Medical Center Utrecht, University of California San Francisco, University of Chicago Medical Center, University of Sydney, Vu University Medical Center Amsterdam, Weill Cornell Medical Center |
Primary outcome
Postoperative blood pressure measurement
Time frame: 6 months postoperative
systolic and diastolic blood pressure via office blood pressure measurements
antihypertensive medication use
Time frame: 6 months postoperative (corresponding to the entered postoperative blood pressure)
number of antihypertensives in defined daily dose
resolution of hypertension
Time frame: 6 months postoperative
resolution of hypertension score via the PASO consensus criteria
6 secondary outcomes
Postoperative serum potassium level
Time frame: 6 months postoperative
Postoperative plasma aldosterone level in lying and standing position
Time frame: 6 months postoperative
Postoperative plasma renin activity in lying and standing position
Time frame: 6 months postoperative
Postoperative aldosterone to renin ratio
Time frame: 6 months postoperative
Postoperative plasma creatinine level
Time frame: 6 months postoperative
Pathology
Time frame: 6 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 28576687Williams 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.
- Background: PubMed 18376197Zarnegar 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.
- Background: PubMed 22000827Utsumi 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.
- Background: PubMed 25456916Aronova 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.
- Background: PubMed 14597859Stowasser 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.
- Results publication: PubMed 30810749Vorselaars 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.
- Results publication: PubMed 31053245Vorselaars 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.
- Results publication: PubMed 31270571Vorselaars 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.
- Results publication: PubMed 32025781Vorselaars 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menno R Vriens, MD principal investigator
UMC Utrecht
Gerlof D Valk, MD study director
UMC Utrecht
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism Due to Aldosterone Producing Adenoma and Primary Aldosteronism, run by UMC Utrecht at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Netherlands, Canada, Australia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative blood pressure measurement (time frame: 6 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761354, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.