Omics Signature in the Diagnosis of Hypertension
- Conditions
- Hypertension
- Interventions
- Other: omics
- Registration Number
- NCT02772315
- Lead Sponsor
- Radboud University Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4000
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hypertensive patients omics Diagnostic procedures in patients with hypertension applying omics results
- Primary Outcome Measures
Name Time Method negative predictive value 1 year negative predictive values of omics signatures for the diagnosis of subtypes of hypertension
positive likelihood ratio 1 year positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension
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
negative likelihood ratio 1 year negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension
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 predictive value 1 year positive predictive values of omics signatures for the diagnosis of subtypes of hypertension
- Secondary Outcome Measures
Name Time Method Left ventricular mass as assessed by echocardiography 1 year Left ventricular mass index measured by ultrasound imaging
Ambulatory blood pressure measurement (ABPM) 1 year ABPM
Home blood pressure measurement (HBPM) 1 year HBPM
number of antihypertensive drugs 1 year number of antihypertensive drugs
Montreal Cognitive Assessment (MOCA) 1 year Assessment of cognitive functioning by MOCA
Costs 1 year Questionnaires on costs of evaluation, costs of misdiagnosis
EQ5D 1 year Quality of life assessment by the EQ5D questionnaire
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
RAND-36 1 year Quality of life assessment by the RAND-36 questionnaire
Cognitive Functioning Questionnaire (CFQ) 1 year Assessment of cognitive functioning by CFQ
microalbuminuria 1 year albumin-creatinine ratio in urine
atrial fibrillation 1 year atrial fibrillation as assessed by EKG
Hospital Anxiety and Depression Scale (HADS) 1 year Assessment of anxiety and depression by the HADS questionnaire
defined daily dosages 1 year defined daily dosages of antihypertensive drugs
Trial Locations
- Locations (5)
University of Torino
🇮🇹Torino, Italy
Raddboudumc
🇳🇱Nijmegen, Gelderland, Netherlands
University of Padua
🇮🇹Padua, Italy
University of Glasgow
🇬🇧Glasgow, United Kingdom
European Georges Pompidou Hospital
🇫🇷Paris, France