Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761354
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2021-02-10
Brief Title:
Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism a Multicenter Analysis
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism a Multicenter Analysis
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None