Omics Signature in the Diagnosis of Hypertension

NCT02772315 | Unknown

• 1 other identifier: ENSAT-HT-2016-01
• Study Type: observational
• Target: 4,000
• Locations: 4 countries
• Sites: 5

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.

Conditions

Hypertension

Keywords

genomics; proteomics; metabolomics; endocrine hypertension; primary aldosteronism; Cushing syndrom; pheochromocytoma

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• positive likelihood ratio

  positive likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension

  1 year

• negative likelihood ratio

  negative likelihood ratios of omics signatures for the diagnosis of subtypes of hypertension

  1 year

• positive predictive value

  positive predictive values of omics signatures for the diagnosis of subtypes of hypertension

  1 year

• negative predictive value

  negative predictive values of omics signatures for the diagnosis of subtypes of hypertension

  1 year

Secondary Outcomes (14)

• Occurrence of major adverse cardiovascular events (MACE)

  within 12 months after baseline

• Left ventricular mass as assessed by echocardiography

  1 year

• Costs

  1 year

• Ambulatory blood pressure measurement (ABPM)

  1 year

• microalbuminuria

  1 year

Study Arms (1)

Hypertensive patients

Diagnostic procedures in patients with hypertension applying omics results

Other: omics

Interventions

omics OTHER

diagnostic procedures applying omics results

Hypertensive patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects referred for diagnosis and management of hypertension

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• European Georges Pompidou Hospital: collaborator
• University of Turin, Italy: collaborator
• University of Padova: collaborator
• University of Glasgow: collaborator

Study Sites (5)

European Georges Pompidou Hospital

Paris, 75015, France

RECRUITING

University of Padua

Padua, Italy

NOT YET RECRUITING

University of Torino

Torino, Italy

NOT YET RECRUITING

Raddboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

University of Glasgow

Glasgow, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism; Pheochromocytoma

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Maria Christina Zennaro, PhD

  AP/HECP, Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Amar, PD PhD

CONTACT

+33156093771; laurence.amar@aphp.fr

Jaap Deinum, MD PhD

CONTACT

+31 24 3618819; jaap.deinum@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 13, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

GB (1); FR (1); IT (2); NL (1)