Omics Signature in the Diagnosis of Hypertension

Hypertension Clinical Trial

— ENSAT-HT  

Official title:

Performance of an Omics-signature in the Diagnosis and Prognosis of Endocrine and Primary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772315
• Other study ID #: ENSAT-HT-2016-01
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: January 25, 2017
• Start date: August 2016
• Est. completion date: May 2019

Study information

• Verified date: January 2017
• Source: Radboud University
• Contact: Laurence Amar, PD PhD
• Phone: +33156093771
• Email: laurence.amar[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• omics
diagnostic procedures applying omics results

Locations

Country	Name	City	State
France	European Georges Pompidou Hospital	Paris
Italy	University of Padua	Padua
Italy	University of Torino	Torino
Netherlands	Raddboudumc	Nijmegen	Gelderland
United Kingdom	University of Glasgow	Glasgow

Sponsors (5)

Lead Sponsor	Collaborator
Radboud University	European Georges Pompidou Hospital, University of Glasgow, University of Padua, University of Turin, Italy

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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.	1 year
Primary	positive likelihood ratio	positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension	1 year
Primary	negative likelihood ratio	negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension	1 year
Primary	positive predictive value	positive predictive values of omics signatures for the diagnosis of subtypes of hypertension	1 year
Primary	negative predictive value	negative predictive values of omics signatures for the diagnosis of subtypes of hypertension	1 year
Secondary	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	within 12 months after baseline
Secondary	Left ventricular mass as assessed by echocardiography	Left ventricular mass index measured by ultrasound imaging	1 year
Secondary	Costs	Questionnaires on costs of evaluation, costs of misdiagnosis	1 year
Secondary	Ambulatory blood pressure measurement (ABPM)	ABPM	1 year
Secondary	microalbuminuria	albumin-creatinine ratio in urine	1 year
Secondary	atrial fibrillation	atrial fibrillation as assessed by EKG	1 year
Secondary	RAND-36	Quality of life assessment by the RAND-36 questionnaire	1 year
Secondary	EQ5D	Quality of life assessment by the EQ5D questionnaire	1 year
Secondary	Hospital Anxiety and Depression Scale (HADS)	Assessment of anxiety and depression by the HADS questionnaire	1 year
Secondary	Cognitive Functioning Questionnaire (CFQ)	Assessment of cognitive functioning by CFQ	1 year
Secondary	Montreal Cognitive Assessment (MOCA)	Assessment of cognitive functioning by MOCA	1 year
Secondary	Home blood pressure measurement (HBPM)	HBPM	1 year
Secondary	number of antihypertensive drugs	number of antihypertensive drugs	1 year
Secondary	defined daily dosages	defined daily dosages of antihypertensive drugs	1 year