To setup and validate an accessible, non-invasive method to enable earlier and more precise classification of patients with an elevated or high blood pressure.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Agreement between existing (clinically used) methods and newly developed
methods for determining: arterial wall properties (distensibility as function
of pressure) and left ventricular geometry (dilated or not, wall thickened or
not).
2. Reproducibility of the new methods, which determines the ability to track
changes in functional and structural aspects of cardiovascular interaction over
time.
Secondary outcome
Possible contribution of the new methods to the clinical diagnosis and
treatment of hypertensive patients. (By retrospective analysis by physician.)
Background summary
High blood pressure is a risk factor for occurrence of stroke and myocardial
infarction. Clinical management of high blood pressure strongly depends on
diagnostic findings. A thickened cardiac muscle wall, as assessed by
echocardiography, indicates the heart has been pumping against a higher
pressure for sometime already. Such findings, in combination with
well-documented high blood pressure, determine the kind of treatment
(aggressive/conservative). However, relevant diagnostic methods are too
comprehensive and costly to use in many patients.
Study objective
To setup and validate an accessible, non-invasive method to enable earlier and
more precise classification of patients with an elevated or high blood
pressure.
Study design
The study investigates possibilities to assess cardiovascular condition by a
limited number of non-invasive measurements. Carotid artery diameter and the
local blood pressure curve will be measured, providing direct information on
arterial distensibility. The measurement data will be fed to a
biomechanical/physiological computermodel to obtain an estimate of the
condition of the heart. Standard clinical echocardiography will serve as a
benchmark.
Comparative methods will be used to evaluate agreement between existing and new
methods within each individual and over a follow-up period. Reproducibility and
accuracy of the new methods are thus determined.
Study burden and risks
Quite small: measurement methods are non-invasive and pose minimal burden.
Required extra time of the patient (in total 3 times 1 hour, spread over 6-9
months) is limited, because other clinical assessments take place at the same
days on which the patient is already visiting the hospital or outpatient
clinic.
Universiteitssingel 50
6229ER Maastricht
Nederland
Universiteitssingel 50
6229ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
documented high blood pressure, age above 18
Exclusion criteria
pregnancy, intended pregnancy, hypertensive urgency or emergency, cardiac arrhythmias, severe obesity precluding echo and tonometric assessment
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 | NL31582.068.10 |