HT-ENDO: A Multiomics-based Biomarker for the Diagnosis of Endocrine Hypertension: a Pragmatic, Diagnostic, Randomized, Outcome-based Trial
NCT Number: NCT06578975
Acronym: HT-ENDO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: DIAGNOSTIC_TEST: HT-ENDO-MOS-A13|OTHER: Normal diagnosis
Sponsor: JDeinum
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11-01
Completion Date: 2026-01-01

Summary:
Rationale: Diagnosis of endocrine forms of hypertension (primary aldosteronism, pheochromocytoma/paraganglioma 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 parameters/endpoints:

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 In the biomarker group, endocrine tests will have been replaced by a blood and urine collection.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.

Primary Outcome Measures: Potency of antihypertensive medication, 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., from date of start of treament until end of study evaluation (6 months)
Secondary Outcome Measures: Ambulatory blood pressure, Ambulatory blood pressure decrease comparison of the two diagnostic methods, from date of start of treament until end of study evaluation (6 months)|Biochemical cure of endocrine hypertension (if treated by surgery), Comparison of effectiveness of biochemical cure of endocrine hypertension (if treated by surgery) As defined by normalisation of aldosterone and renin levels in case of adrenalectomy for aldosterne producing adenoma, normalization of (nor)metanephrine levels after surgery for pheochromocytoma, or normalization of cortisol levels after hypophysectomy or adrenalectomy in Cushing disease/syndrome., from date of start of treament until end of study evaluation (6 months)|Cost, Cost-effectiveness comparison between the two diagnostic methods.for a cost-effectiveness analysis we will use the costs of all procedures and the results of the EQ-5D questionnaire., from date of randomization until end of study evaluation (6 months)|Quality of life EQ-5D (min 00000- max 55555, with 55555 having the best quality of life), Quality of life comparison between participants in the two arms using the EQ-5D, from date of start of treament until end of study evaluation (6 months)|Quality of life SF-36 (36-Item Short Form Health Survey, 0-100 for each scale, lower means worse qulaity of life), Quality of life comparison between participants in the two arms using the SF-36, from date of start of treament until end of study evaluation (6 months)
Other Outcome Measures: Extra standard analysis, proportion of participants diagnosed with PHT in the intervention MOMICS-ENDO arm who choose to undergo a standard analysis after the end of follow-up, From end of follow-up of trial to initial diagnosis confirmed or not (around 3 months)|EHT after secondary standard analysis, number of participants with PHT in the MOMICS-ENDO arm who have EHT after a secondary standard analysis after the end of follow-up., From end of follow-up of trial to initial diagnosis confirmed or not (around 3 months)|carbon footprints of both arms, comparison of the carbon footprints of both arms, from inclusion to end of follow-up (6 months after start of treatment)