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NCT04761354 · ClinicalTrials.gov registry record
Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
A clinical trial of Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, sponsored by UMC Utrecht.
- Completed
- Registry status
- 514
- Enrollment target
- 14
- Study locations
NCT04761354 is a study of Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma that has completed, run by UMC Utrecht. The registered enrollment target is 514 participants, below the 3,143-participant average among 4 other Primary Aldosteronism trials with a reported enrollment target (84% lower). The trial reports 14 study locations across 12 states.
The verdict
NCT04761354, a study of Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, has completed, sponsored by UMC Utrecht.
- COMPLETED
- Registry status
- 514 participants
- Enrollment target
- 14
- Study locations
Study 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 releva
Conditions Studied
Interventions
- PROCEDURE Unilateral adrenalectomy
Study Locations (14)
Illinois
- Northwestern Memorial Hospital - Chicago
- University of Chicago Medical Center - Chicago
New York
- Columbia University Medical Center - New York
- Weill Cornell Medical College - New York
California
- University of California San Francisco - San Francisco
Massachusetts
- Boston Medical Center - Boston
Texas
- M.D. Anderson Cancer Center - Houston
New South Wales
- University of Sydney - Sydney
Ontario
- University Health Network Toronto - Toronto
Quebec
- Montreal General Hospital - McGill University - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2016-03-26 |
| Est. Completion | 2017-03-26 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04761354
The ClinicalTrials.gov registry entry for NCT04761354 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,143-participant average among 4 other Primary Aldosteronism trials with a reported enrollment target (84% lower). The listed sponsor is UMC Utrecht, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Primary Aldosteronism appearing as the primary indexed condition, and to 1 intervention - of which Unilateral adrenalectomy is the first listed.
NCT04761354 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Illinois, New York, California.
Frequently Asked Questions
What is clinical trial NCT04761354 about?
NCT04761354 is a clinical study titled "Predicting Reduction of Hypertension After 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 pre...
What is the current status of trial NCT04761354?
This trial is currently completed. The enrollment target is 514 participants. The study started on 2016-03-26. Estimated completion is 2017-03-26.
What conditions does trial NCT04761354 study?
This clinical trial studies the following conditions: Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Conn Adenoma.
What interventions are being tested in trial NCT04761354?
The interventions under investigation include: Unilateral adrenalectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04761354?
This trial is sponsored by UMC Utrecht, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04761354 being conducted?
This trial has 14 study locations across California, Illinois, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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