HypertensionHT-ENDONCT06578975
HT-ENDO: A Multiomics-based Biomarker for the Diagnosis of Endocrine Hypertension: a Pragmatic, Diagnostic, Randomized, Outcome-based Trial
A study testing HT-ENDO-MOS-A13 and Normal diagnosis in people with Hypertension, run by JDeinum.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- HT-ENDO-MOS-A13 and Normal diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Have a properly documented hypertension by abpm, hbpm, unattended office blood pressure measurement or carefully performed office measurement.
- Has a physician who feels an urge to exclude or diagnose EHT for one or more of the following reasons
- resistant hypertension AND/OR
- hypokalemia, spontaneous or diuretic-induced AND/OR
- history or physical examination suggestive of endocrine hypertension
- Willingness and ability to give informed consent
Who cannot join
- White-coat hypertension
- Known renal artery stenosis
- Known licorice abuse
- Known familial form of endocrine hypertension
- Cardiovascular event (myocardial infarction, cerebrovascular event) < 6 months [Y/N]
- Hypertensive crisis < 6 months
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- eGFR < 50 ml/min/1,73m2
- Liver failure
- Known severe valvular or structural heart disease (excluding left ventricular hypertrophy)
- NYHA class III or IV heart failure or known reduced left ventricular function (ejection fraction (EF) <30%)
- EKG demonstrating significant pathology (e.g. myocardial infarction, atrial fibrillation, or any other cardial condition prohibiting start of study medication)
- Life expancy < 1 year
- For women, current pregnancy or unprotected intercourse
Trial locations and contacts
No sites are listed yet.
About this study
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
Read more
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.
- Conditions
- Hypertension
- Being tested
- HT-ENDO-MOS-A13, Normal diagnosis
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-ENDO-MOS-A13Diagnostic test
Mutli-Omics based biomarker to diagnose primary hypertension or endocrine forms of hypertension; primary aldosteronism, pheochromocytoma/functional paraganglioma or Cushing syndrome.
Normal diagnosisOther
Standard diagnosis for endocrine hypertension
| Study group | Role | What they receive |
|---|---|---|
| Multi-Omics diagnosis | Experimental | Participants in this arm will be diagnosed with the mutli-omics based biomarker Receives: Diagnostic Test: HT-ENDO-MOS-A13 |
| Normal diagnosis | Other | Not described Receives: Other: Normal diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from date of start of treament until end of study evaluation (6 months)
Secondary outcomes (5)
Ambulatory blood pressure
Ambulatory blood pressure decrease comparison of the two diagnostic methods
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: from date of start of treament until end of study evaluation (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JDeinum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JDeinum, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578975
- Sponsor's protocol ID
- 115632
- Acronym
- HT-ENDO
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HT-ENDO: A Multiomics-based Biomarker for the Diagnosis of Endocrine Hypertension: a Pragmatic, Diagnostic, Randomized, Outcome-based Trial
- ClinicalTrials.gov ID
- NCT06578975
- Acronym / sponsor ID
- HT-ENDO / 115632
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- JDeinumUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Omics diagnosis | Experimental | Diagnostic Test: HT-ENDO-MOS-A13Participants in this arm will be diagnosed with the mutli-omics based biomarker |
| Normal diagnosis | Other | Other: Normal diagnosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- Have a properly documented hypertension by abpm, hbpm, unattended office blood pressure measurement or carefully performed office measurement.
- Has a physician who feels an urge to exclude or diagnose EHT for one or more of the following reasons
- resistant hypertension AND/OR
- hypokalemia, spontaneous or diuretic-induced AND/OR
Key exclusion criteria (13 listed)
- White-coat hypertension
- Known renal artery stenosis
- Known licorice abuse
- Known familial form of endocrine hypertension
- Cardiovascular event (myocardial infarction, cerebrovascular event) < 6 months [Y/N]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HT-ENDO-MOS-A13Mutli-Omics based biomarker to diagnose primary hypertension or endocrine forms of hypertension; primary aldosteronism, pheochromocytoma/functional paraganglioma or Cushing syndrome. | Diagnostic test | Multi-Omics diagnosis |
| Normal diagnosisStandard diagnosis for endocrine hypertension | Other | Normal diagnosis |
Primary outcome
Potency of antihypertensive medication
Time frame: from date of start of treament until end of study evaluation (6 months)
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.
5 secondary outcomes
Ambulatory blood pressure
Time frame: from date of start of treament until end of study evaluation (6 months)
Biochemical cure of endocrine hypertension (if treated by surgery)
Time frame: from date of start of treament until end of study evaluation (6 months)
Cost
Time frame: 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)
Time frame: 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)
Time frame: from date of start of treament until end of study evaluation (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing HT-ENDO-MOS-A13 and Normal diagnosis in people with Hypertension, run by JDeinum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Secretary Internal Medicine ((024) 361 65 04 ext. +31, secretariaatstaf.aig@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potency of antihypertensive medication (time frame: from date of start of treament until end of study evaluation (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.