Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578975
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-11
Brief Title:
HT-ENDO A Multiomics-based Biomarker for the Diagnosis of Endocrine Hypertension a Pragmatic Diagnostic Randomized Outcome-based Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HT-ENDO A Multiomics-based Biomarker for the Diagnosis of Endocrine Hypertension a Pragmatic Diagnostic Randomized Outcome-based Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HT-ENDO
Brief Summary:
Rationale Diagnosis of endocrine forms of hypertension primary aldosteronism pheochromocytomaparaganglioma and Cushing syndrome is a lengthy and tedious process Recently a multiomics biomarker was developed through machine learning that shows high accuracy in predicting the presence of endocrine hypertension or primary hypertension Given the propensity to data shift in applications of machine learning derived algorithms validation of this multiomics biomarker in a prospective comparative trial is warranted
Objective To determine the diagnostic performance of the new diagnostic biomarker
Study design A randomized diagnostic outcome-based trial
Study population Hypertensive patients 18-75 yrs referred to ESH Hypertension Excellence centers who may suffer from endocrine hypertension
Intervention if applicable One group is diagnosed by classic endocrine tests the other by the multiomics biomarker Ensuing treatment depends on diagnosis and subtyping results
Main study parametersendpoints
Primary endpoint is potency of antihypertensive medication to reach a target systolic blood pressure value of 135 mm Hg by home blood pressure measurement or an equivalent value for ambulatory blood pressure measurement standardized office blood pressure measurement or unattended automatic blood pressure measurement
Secondary endpoints Ambulatory blood pressure biochemical cure of endocrine hypertension if treated by surgery costs quality of life
Nature and extent of the burden and risks associated with participation benefit and group relatedness In the control group patients follow the same diagnostic itinerary as in usual care In the biomarker group endocrine tests will have been replaced by a blood and urine collection The risk in both arms consists of missing an endocrine diagnosis From the preceding accuracy study this risk is low for the use of the biomarker After 6 months follow-up patients that were diagnosed by the biomarker may switch to a classic analysis
Objective To determine the diagnostic performance of the new diagnostic biomarker
Study design A randomized diagnostic outcome-based trial
Study population Hypertensive patients 18-75 yrs referred to ESH Hypertension Excellence centers who may suffer from endocrine hypertension
Intervention if applicable One group is diagnosed by classic endocrine tests the other by the multiomics biomarker Ensuing treatment depends on diagnosis and subtyping results
Main study parametersendpoints
Primary endpoint is potency of antihypertensive medication to reach a target systolic blood pressure value of 135 mm Hg by home blood pressure measurement or an equivalent value for ambulatory blood pressure measurement standardized office blood pressure measurement or unattended automatic blood pressure measurement
Secondary endpoints Ambulatory blood pressure biochemical cure of endocrine hypertension if treated by surgery costs quality of life
Nature and extent of the burden and risks associated with participation benefit and group relatedness In the control group patients follow the same diagnostic itinerary as in usual care In the biomarker group endocrine tests will have been replaced by a blood and urine collection The risk in both arms consists of missing an endocrine diagnosis From the preceding accuracy study this risk is low for the use of the biomarker After 6 months follow-up patients that were diagnosed by the biomarker may switch to a classic analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None