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Performance of an omics-signature in the diagnosis and prognosis of endocrine and primary hypertension A sub study of the ENSAT-HT Horizon 2020 project

Performance of an omics-signature in the diagnosis and prognosis of endocrine and primary hypertension A sub study of the ENSAT-HT Horizon 2020 project - ENSAT-HT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42833
Enrollment
400
Registered
2016-06-29
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensie High blood pressure

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged from 18 to 75 years old - A signed and dated informed consent form - A diagnosis of hypertension defined either as: o Use of antihypertensive drug (s) o 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

Exclusion criteria: potential subject who meets any of the following criteria will be excluded from participation in the prospective cohort is any of the following criteria will be present: - 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 - Drug-induced hypertension - Documented non-adherence to medication

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the diagnostic performance (sensitivity, specificity, positive and negative predictive value and diagnostic odds ratios) of omics to diagnose EHBP.

Secondary

MeasureTime frame
The secondary endpoints are defined as following: - Occurrence of major adverse cardiovascular events (MACE) within 12 months after V1 defined as: 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. - Left ventricular (LV) hypertrophy, microalbuminuria, atrial fibrillation - Quality of life and 'psychomics': , RAND36, (quality of life), EQ5D (quality of life), HADS (anxiety and depression), CFQ (cognitive functioning) and MOCA (cognitive functioning) - costs (cost of evaluation, cost of misdiagnosis) - BP level on ABPM/HBPM, number of drugs, Defined Daily Dosages (DDD) (http://www.whocc.no/ddd/definition_and_general_considera/)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)