Hypertension
Conditions
Keywords
genomics, proteomics, metabolomics, endocrine hypertension, primary aldosteronism, Cushing syndrom, pheochromocytoma
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.
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.
Interventions
OTHERomics
diagnostic procedures applying omics results
Sponsors
European Georges Pompidou Hospital
University of Turin, Italy
University of Padova
University of Glasgow
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivities of omics signatures for the diagnosis of subtypes of hypertension | 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 | 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 | 1 year | positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension |
| negative likelihood ratio | 1 year | negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension |
| positive predictive value | 1 year | positive predictive values of omics signatures for the diagnosis of subtypes of hypertension |
| negative predictive value | 1 year | negative predictive values of omics signatures for the diagnosis of subtypes of hypertension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAND-36 | 1 year | Quality of life assessment by the RAND-36 questionnaire |
| EQ5D | 1 year | Quality of life assessment by the EQ5D questionnaire |
| Hospital Anxiety and Depression Scale (HADS) | 1 year | Assessment of anxiety and depression by the HADS questionnaire |
| Cognitive Functioning Questionnaire (CFQ) | 1 year | Assessment of cognitive functioning by CFQ |
| Occurrence of major adverse cardiovascular events (MACE) | 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 |
| Home blood pressure measurement (HBPM) | 1 year | HBPM |
| number of antihypertensive drugs | 1 year | number of antihypertensive drugs |
| defined daily dosages | 1 year | defined daily dosages of antihypertensive drugs |
| Montreal Cognitive Assessment (MOCA) | 1 year | Assessment of cognitive functioning by MOCA |
| Left ventricular mass as assessed by echocardiography | 1 year | Left ventricular mass index measured by ultrasound imaging |
| Costs | 1 year | Questionnaires on costs of evaluation, costs of misdiagnosis |
| Ambulatory blood pressure measurement (ABPM) | 1 year | ABPM |
| microalbuminuria | 1 year | albumin-creatinine ratio in urine |
| atrial fibrillation | 1 year | atrial fibrillation as assessed by EKG |
Countries
France, Italy, Netherlands, United Kingdom
Contacts
Primary ContactLaurence Amar, PD PhD
Backup ContactJaap Deinum, MD PhD
Outcome results
None listed