: The main objective of WP4 is to assess the validity and usefulness of omics signatures identified and validated in WPs 1, 2 and 3 for improved identification and risk stratification of patients with EHBP and stratification of patients with PHT.The…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the diagnostic performance (sensitivity, specificity,
positive and negative predictive value and diagnostic odds ratios) of omics to
diagnose EHBP.
Secondary outcome
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/)
Background summary
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.
Study objective
: The main objective of WP4 is to assess the validity and usefulness of omics
signatures identified and validated in WPs 1, 2 and 3 for improved
identification and risk stratification of patients with EHBP and stratification
of patients with PHT.
The specific objectives of the WP are:
- To compare the diagnostic accuracy of omics-based signatures for identifying
patients with EHBP compared with standard procedures.
- To determine the prognostic value of the omics signatures by assessing their
relationship with outcome measures after one year follow-up, including BP, BP
related target organ damage (TOD) and Quality of Life (QoL).
- To assess the potential usefulness of the omics signatures for stratification
of patients with PHT.
- To relate the use of omics signatures to the social impact of hypertension,
including QoL, degree of psychosocial burden, patients* lives and economic
effects
Study design
Prospective observational multi-centre cohort study in which we will compare
the diagnostic value of -omics signatures with currently used diagnostic
methods to detect adrenal forms of hypertension. The omics signatures will be
identified from biobanks obtained in retrospective historical cohorts of more
than 500 patients with confirmed adrenal hypertension by integrating high
throughput genetics, genomics and metabolomics data with phenome annotations
through bioinformatics modeling. Nested case-control studies of endocrine
hypertension and primary hypertension will be used for follow-up.
Study burden and risks
In this study hypertensive patients will be diagnosed applying usual diagnostic
algorithms . The only burden of participation is the sampling of extra blood
and urine at the start of the diagnostic phase and at the end of the follow-up
period and filling out Quality of Life (QoL) questionnaires.
Geert-Grooteplein 10
Nijmegen 6525 GA
NL
Geert-Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57215.091.16 |