HypertensionENSAT-HTNCT02772315
Omics Signature in the Diagnosis of Hypertension
An observational study of Hypertension, run by Radboud University Medical Center at 5 sites in 4 countries.
Trial summary
The purpose of this study is to assess the validity and usefulness of omics signatures for improved identification and risk stratification of patients with endocrine hypertension and stratification of patients with primary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- omics
- How many people
- 4,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Aug 2016to May 2019
- Phase
- Observational
- 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
Study population: Subjects referred for diagnosis and management of hypertension
Who may be able to join
- Aged from 18 to 75 years old
- A signed and dated informed consent form
- A diagnosis of hypertension defined either as:
- Use of antihypertensive drug (s)
- Arterial hypertension: in untreated patients this must be confirmed by daytime ambulatory blood pressure monitoring (ABPM), or home blood pressure monitoring, with blood pressure higher or equal to 135 mmHg for systolic blood pressure and/or higher or equal to 85 mmHg for diastolic blood pressure.
- In order to be eligible to participate in the nested case control study, a subject must also meet the following criteria:
- A conformed diagnosis of PA, PPGL or CS for case patients and PHT (exclusion of secondary forms) for their matched counterparts
Who cannot join
- Any severe comorbid conditions that, according to the attending physician, could decrease the life expectancy to less than 3 years
- Any active malignancy unrelated to adrenal disease or PPGL
- Guardianship for incapacity
- A potential control subject who meets any of the following criteria will be excluded from participation in the nested case controlled study in case of:
- Existence of any other forms of secondary hypertension such as renal artery stenosis, renal disease, Munchausen's syndrome in which the patient induces hypertension regardless of method.
- Drug-induced (included factitious use of illicit substances) hypertension
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Italy2 sites, 2 recruiting
- Not yet recruiting
University of Padua
Padua
Gian Paolo Rossi
- Not yet recruiting
University of Torino
Torino
Paolo Mulatero
France1 site, 1 recruiting
- Recruiting
European Georges Pompidou Hospital
Paris, 75015
Laurence Amar, MD, PhD, 33156093771, laurence.amar@aphp.fr
Michel Azizi, PD, PhD, 33156093771, michel.azizi@aphp.fr
Netherlands1 site, 1 recruiting
- Recruiting
Raddboudumc
Nijmegen, Gelderland, 6525 GA
Joyce Koffeman, MSc., +31 24 3618819, joyce.koffeman-smeltink@radboudumc.nl
Jaap Deinum, MD PhD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University of Glasgow
Glasgow
Eleonore Davis
About this study
Official title: Performance of an Omics-signature in the Diagnosis and Prognosis of Endocrine and Primary Hypertension
The purpose of this study is to assess the validity and usefulness of omics signatures for improved identification and risk stratification of patients with endocrine hypertension and stratification of patients with primary hypertension.
Read the detailed description
Arterial hypertension is the most important cause of death in the world. At referral hypertension centers about 25% of patients have a single cause for hypertension, so-called secondary hypertension, mostly of endocrine, adrenal origin (primary aldosteronism, pheochromocytoma/ paraganglioma, Cushing's syndrome). This rate steps up to 50% in patients with drug resistant hypertension. Proper treatment of secondary hypertension improves prognosis considerably but depends on adequate diagnosis. Classically the diagnosis of such forms of hypertension rests on cumbersome biochemical and imaging procedures that may not completely take away uncertainty. Modern '-omics' techniques (genomics, metabolomics, proteomics of plasma and urine) may allow faster and better diagnosis. In addition, they may provide a basis for stratification of hypertensive patients that do not have a identifiable cause of hypertension, so-called primary hypertension. This stratification may help predicting response to antihypertensive drugs and determining prognosis and thus, help to establish personalized medicine in hypertension care.
- Conditions
- Hypertension
- Being tested
- omics
- Keywords
- genomics, proteomics, metabolomics, endocrine hypertension, primary aldosteronism, Cushing syndrom, pheochromocytoma
- Medical subject headings
- Hypertension, Hyperaldosteronism, Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omicsOther
diagnostic procedures applying omics results
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Diagnostic procedures in patients with hypertension applying omics results Receives: Other: omics |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivities of omics signatures for the diagnosis of subtypes of hypertension
The proportion of patients with various subtypes of endocrine hypertension as identified by omics signature in patients in which subtypes have been identified by usual diagnostic algorithms
Measured: 1 year
specificities of omics signatures for the diagnosis of subtypes of hypertension
The proportion of patients with non-endocrine hypertension as identified by omics signature in patients identified as having non-endocrine hypertension by usual diagnostic algorithms.
Measured: 1 year
positive likelihood ratio
positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension
Measured: 1 year
negative likelihood ratio
negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension
Measured: 1 year
positive predictive value
positive predictive values of omics signatures for the diagnosis of subtypes of hypertension
Measured: 1 year
negative predictive value
negative predictive values of omics signatures for the diagnosis of subtypes of hypertension
Measured: 1 year
Secondary outcomes (14)
Occurrence of major adverse cardiovascular events (MACE)
death, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or need for them, cerebrovascular accident (CVA), hospitalization for acute decompensated heart failure
Measured: within 12 months after baseline
Left ventricular mass as assessed by echocardiography
Left ventricular mass index measured by ultrasound imaging
Measured: 1 year
Costs
Questionnaires on costs of evaluation, costs of misdiagnosis
Measured: 1 year
Ambulatory blood pressure measurement (ABPM)
ABPM
Measured: 1 year
microalbuminuria
albumin-creatinine ratio in urine
Measured: 1 year
atrial fibrillation
atrial fibrillation as assessed by EKG
Measured: 1 year
RAND-36
Quality of life assessment by the RAND-36 questionnaire
Measured: 1 year
EQ5D
Quality of life assessment by the EQ5D questionnaire
Measured: 1 year
Hospital Anxiety and Depression Scale (HADS)
Assessment of anxiety and depression by the HADS questionnaire
Measured: 1 year
Cognitive Functioning Questionnaire (CFQ)
Assessment of cognitive functioning by CFQ
Measured: 1 year
Montreal Cognitive Assessment (MOCA)
Assessment of cognitive functioning by MOCA
Measured: 1 year
Home blood pressure measurement (HBPM)
HBPM
Measured: 1 year
number of antihypertensive drugs
number of antihypertensive drugs
Measured: 1 year
defined daily dosages
defined daily dosages of antihypertensive drugs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Georges Pompidou Hospital, University of Turin, Italy, University of Padova, University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Maria Christina Zennaro, PhD, Principal investigator, AP/HECP, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772315
- Sponsor's protocol ID
- ENSAT-HT-2016-01
- Acronym
- ENSAT-HT
- Status last verified
- Jan 2017
- First submitted
- 22 Mar 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of an Omics-signature in the Diagnosis and Prognosis of Endocrine and Primary Hypertension
- ClinicalTrials.gov ID
- NCT02772315
- Acronym / sponsor ID
- ENSAT-HT / ENSAT-HT-2016-01
- Conditions
- Hypertension
- Keywords
- genomics, proteomics, metabolomics, endocrine hypertension, primary aldosteronism, Cushing syndrom, pheochromocytoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- European Georges Pompidou Hospital, University of Turin, Italy, University of Padova, University of Glasgow
- Study start
- Aug 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 13 May 2016 (estimated)
- 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.
The purpose of this study is to assess the validity and usefulness of omics signatures for improved identification and risk stratification of patients with endocrine hypertension and stratification of patients with primary hypertension.
Detailed description
Arterial hypertension is the most important cause of death in the world. At referral hypertension centers about 25% of patients have a single cause for hypertension, so-called secondary hypertension, mostly of endocrine, adrenal origin (primary aldosteronism, pheochromocytoma/ paraganglioma, Cushing's syndrome). This rate steps up to 50% in patients with drug resistant hypertension. Proper treatment of secondary hypertension improves prognosis considerably but depends on adequate diagnosis. Classically the diagnosis of such forms of hypertension rests on cumbersome biochemical and imaging procedures that may not completely take away uncertainty. Modern '-omics' techniques (genomics, metabolomics, proteomics of plasma and urine) may allow faster and better diagnosis. In addition, they may provide a basis for stratification of hypertensive patients that do not have a identifiable cause of hypertension, so-called primary hypertension. This stratification may help predicting response to antihypertensive drugs and determining prognosis and thus, help to establish personalized medicine in hypertension care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Other: omicsDiagnostic procedures in patients with hypertension applying omics results |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred for diagnosis and management of hypertension
Key inclusion criteria (7 listed)
- Aged from 18 to 75 years old
- A signed and dated informed consent form
- A diagnosis of hypertension defined either as:
- In order to be eligible to participate in the nested case control study, a subject must also meet the following criteria:
- A conformed diagnosis of PA, PPGL or CS for case patients and PHT (exclusion of secondary forms) for their matched counterparts
Key exclusion criteria (6 listed)
- Any severe comorbid conditions that, according to the attending physician, could decrease the life expectancy to less than 3 years
- Any active malignancy unrelated to adrenal disease or PPGL
- Guardianship for incapacity
- A potential control subject who meets any of the following criteria will be excluded from participation in the nested case controlled study in case of:
- Existence of any other forms of secondary hypertension such as renal artery stenosis, renal disease, Munchausen's syndrome in which the patient induces hypertension regardless of method.
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 |
|---|---|---|
| omicsdiagnostic procedures applying omics results | Other | Hypertensive patients |
Primary outcome
sensitivities of omics signatures for the diagnosis of subtypes of hypertension
Time frame: 1 year
The proportion of patients with various subtypes of endocrine hypertension as identified by omics signature in patients in which subtypes have been identified by usual diagnostic algorithms
specificities of omics signatures for the diagnosis of subtypes of hypertension
Time frame: 1 year
The proportion of patients with non-endocrine hypertension as identified by omics signature in patients identified as having non-endocrine hypertension by usual diagnostic algorithms.
positive likelihood ratio
Time frame: 1 year
positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension
negative likelihood ratio
Time frame: 1 year
negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension
positive predictive value
Time frame: 1 year
positive predictive values of omics signatures for the diagnosis of subtypes of hypertension
negative predictive value
Time frame: 1 year
negative predictive values of omics signatures for the diagnosis of subtypes of hypertension
14 secondary outcomes
Occurrence of major adverse cardiovascular events (MACE)
Time frame: within 12 months after baseline
Left ventricular mass as assessed by echocardiography
Time frame: 1 year
Costs
Time frame: 1 year
Ambulatory blood pressure measurement (ABPM)
Time frame: 1 year
microalbuminuria
Time frame: 1 year
atrial fibrillation
Time frame: 1 year
RAND-36
Time frame: 1 year
EQ5D
Time frame: 1 year
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 year
Cognitive Functioning Questionnaire (CFQ)
Time frame: 1 year
Montreal Cognitive Assessment (MOCA)
Time frame: 1 year
Home blood pressure measurement (HBPM)
Time frame: 1 year
number of antihypertensive drugs
Time frame: 1 year
defined daily dosages
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
Maria Christina Zennaro, PhD principal investigator
AP/HECP, Paris
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Radboud University Medical Center at 5 sites in 4 countries.
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 6 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, France, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Laurence Amar, PD PhD (+33156093771, laurence.amar@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivities of omics signatures for the diagnosis of subtypes of hypertension (time frame: 1 year). The study lists 6 primary outcomes in all. 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 26 Jan 2017.