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Omics Signature in the Diagnosis of Hypertension (ENSAT-HT)

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ClinicalTrials.gov Identifier: NCT02772315
Recruitment Status : Unknown
Verified January 2017 by Radboud University.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
European Georges Pompidou Hospital
University of Turin, Italy
University of Padova
University of Glasgow
Information provided by (Responsible Party):
Radboud University

Brief 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.

Condition or disease Intervention/treatment
Hypertension Other: omics

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of an Omics-signature in the Diagnosis and Prognosis of Endocrine and Primary Hypertension
Study Start Date : August 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hypertensive patients
Diagnostic procedures in patients with hypertension applying omics results
Other: omics
diagnostic procedures applying omics results




Primary Outcome Measures :
  1. 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

  2. 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.

  3. positive likelihood ratio [ Time Frame: 1 year ]
    positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension

  4. negative likelihood ratio [ Time Frame: 1 year ]
    negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension

  5. positive predictive value [ Time Frame: 1 year ]
    positive predictive values of omics signatures for the diagnosis of subtypes of hypertension

  6. negative predictive value [ Time Frame: 1 year ]
    negative predictive values of omics signatures for the diagnosis of subtypes of hypertension


Secondary Outcome Measures :
  1. Occurrence of major adverse cardiovascular events (MACE) [ Time Frame: within 12 months after baseline ]
    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

  2. Left ventricular mass as assessed by echocardiography [ Time Frame: 1 year ]
    Left ventricular mass index measured by ultrasound imaging

  3. Costs [ Time Frame: 1 year ]
    Questionnaires on costs of evaluation, costs of misdiagnosis

  4. Ambulatory blood pressure measurement (ABPM) [ Time Frame: 1 year ]
    ABPM

  5. microalbuminuria [ Time Frame: 1 year ]
    albumin-creatinine ratio in urine

  6. atrial fibrillation [ Time Frame: 1 year ]
    atrial fibrillation as assessed by EKG

  7. RAND-36 [ Time Frame: 1 year ]
    Quality of life assessment by the RAND-36 questionnaire

  8. EQ5D [ Time Frame: 1 year ]
    Quality of life assessment by the EQ5D questionnaire

  9. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 year ]
    Assessment of anxiety and depression by the HADS questionnaire

  10. Cognitive Functioning Questionnaire (CFQ) [ Time Frame: 1 year ]
    Assessment of cognitive functioning by CFQ

  11. Montreal Cognitive Assessment (MOCA) [ Time Frame: 1 year ]
    Assessment of cognitive functioning by MOCA

  12. Home blood pressure measurement (HBPM) [ Time Frame: 1 year ]
    HBPM

  13. number of antihypertensive drugs [ Time Frame: 1 year ]
    number of antihypertensive drugs

  14. defined daily dosages [ Time Frame: 1 year ]
    defined daily dosages of antihypertensive drugs


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects referred for diagnosis and management of hypertension
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772315


Contacts
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Contact: Laurence Amar, PD PhD +33156093771 laurence.amar@aphp.fr
Contact: Jaap Deinum, MD PhD +31 24 3618819 jaap.deinum@radboudumc.nl

Locations
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France
European Georges Pompidou Hospital Recruiting
Paris, France, 75015
Contact: Laurence Amar, MD, PhD    33156093771    laurence.amar@aphp.fr   
Contact: Michel Azizi, PD, PhD    33156093771    michel.azizi@aphp.fr   
Italy
University of Padua Not yet recruiting
Padua, Italy
Contact: Gian Paolo Rossi         
University of Torino Not yet recruiting
Torino, Italy
Contact: Paolo Mulatero         
Netherlands
Raddboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Joyce Koffeman, MSc.    +31 24 3618819    joyce.koffeman-smeltink@radboudumc.nl   
Principal Investigator: Jaap Deinum, MD PhD         
United Kingdom
University of Glasgow Not yet recruiting
Glasgow, United Kingdom
Contact: Eleonore Davis         
Sponsors and Collaborators
Radboud University
European Georges Pompidou Hospital
University of Turin, Italy
University of Padova
University of Glasgow
Investigators
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Principal Investigator: Maria Christina Zennaro, PhD AP/HECP, Paris
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02772315    
Other Study ID Numbers: ENSAT-HT-2016-01
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Keywords provided by Radboud University:
genomics
proteomics
metabolomics
endocrine hypertension
primary aldosteronism
Cushing syndrom
pheochromocytoma
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases