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Procedure

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

N/A
Waitlist Available
Led By Menno R Vriens, MD
Research Sponsored by UMC Utrecht
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months postoperative
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Conn's syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative blood pressure measurement
antihypertensive medication use
resolution of hypertension
Secondary study objectives
Pathology
Postoperative aldosterone to renin ratio
Postoperative plasma aldosterone level in lying and standing position
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups
Experimental Treatment
Group I: Weill Cornell Medical CenterExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group II: Vu University Medical Center AmsterdamExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group III: University of SydneyExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group IV: University of Chicago Medical CenterExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group V: University of California San FranciscoExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group VI: University Medical Center UtrechtExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group VII: University Medical Center MaastrichtExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group VIII: University Medical Center GroningenExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group IX: University Health Network TorontoExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group X: Northwestern Memorial HospitalExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group XI: Montreal General Hospital - McGill UniversityExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group XII: M.D. Anderson Cancer CenterExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group XIII: Istituto di Semeiotica Chirurgica RomaExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group XIV: Columbia University Medical CenterExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group XV: Boston Medical CenterExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Group XVI: Academic Medical Center AmsterdamExperimental Treatment1 Intervention
Patients who underwent adrenalectomy for primary aldosteronism in case of an aldosterone-producing-adenoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unilateral adrenalectomy
2016
N/A
~520

Find a Location

Who is running the clinical trial?

UMC UtrechtLead Sponsor
540 Previous Clinical Trials
2,133,198 Total Patients Enrolled
University Health Network, TorontoOTHER
1,531 Previous Clinical Trials
503,808 Total Patients Enrolled
Catholic University of the Sacred HeartOTHER
309 Previous Clinical Trials
230,452 Total Patients Enrolled
Northwestern Memorial HospitalOTHER
41 Previous Clinical Trials
16,752 Total Patients Enrolled
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,766,611 Total Patients Enrolled
University Medical Center GroningenOTHER
756 Previous Clinical Trials
1,076,197 Total Patients Enrolled
Maastricht University Medical CenterOTHER
980 Previous Clinical Trials
3,301,606 Total Patients Enrolled
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,436 Total Patients Enrolled
Montreal General HospitalOTHER
19 Previous Clinical Trials
9,898 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,092 Previous Clinical Trials
1,154,272 Total Patients Enrolled
~53 spots leftby Dec 2025