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

Primary Aldosteronism Clinical Trial

Official title:

Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761354
• Other study ID #: 16-196/C
• Status: Completed
• Start date: March 26, 2016
• Est. completion date: March 26, 2017

Study information

• Verified date: February 2021
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: March 26, 2017
• Est. primary completion date: March 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adrenocortical Adenoma
• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism
• Primary Aldosteronism Due to Aldosterone Producing Adenoma
• Primary Aldosteronism Due to Conn Adenoma

Intervention

Procedure:
• Unilateral adrenalectomy

Locations

Country	Name	City	State
Australia	University of Sydney	Sydney	New South Wales
Canada	Montreal General Hospital - McGill University	Montréal	Quebec
Canada	University Health Network Toronto	Toronto	Ontario
Italy	Istituto di Semeiotica Chirurgica Roma	Rome	Lazio
Netherlands	Amsterdam University Medical Center	Amsterdam	Noord-Holland
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
United States	Boston Medical Center	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of California San Francisco	San Francisco	California

Sponsors (16)

Lead Sponsor

Collaborator

UMC Utrecht

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Boston Medical Center, Catholic University of the Sacred Heart, Columbia University, M.D. Anderson Cancer Center, Maastricht University Medical Center, Montreal General Hospital, Northwestern Memorial Hospital, University Health Network, Toronto, University Medical Center Groningen, University of California, San Francisco, University of Chicago, University of Sydney, VU University Medical Center, Weill Medical College of Cornell University

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,  Netherlands, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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, Sywa — View Citation

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 — View Citation

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. d — View Citation

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 Worldwid — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative blood pressure measurement	systolic and diastolic blood pressure via office blood pressure measurements	6 months postoperative
Primary	antihypertensive medication use	number of antihypertensives in defined daily dose	6 months postoperative (corresponding to the entered postoperative blood pressure)
Primary	resolution of hypertension	resolution of hypertension score via the PASO consensus criteria	6 months postoperative
Secondary	Postoperative serum potassium level	Serum potassium in mmol/l.	6 months postoperative
Secondary	Postoperative plasma aldosterone level in lying and standing position	Plasma aldosterone in nmol/l.	6 months postoperative
Secondary	Postoperative plasma renin activity in lying and standing position	Plasma renin activity in mg/L/u.	6 months postoperative
Secondary	Postoperative aldosterone to renin ratio	Aldosterone to renin ratio using plasma aldosterone level and plasma renin activity	6 months postoperative
Secondary	Postoperative plasma creatinine level	Plasma creatinine in mg/dL	6 months postoperative
Secondary	Pathology	Final result of pathology after adrenalectomy	6 months postoperative