1. to investigate early haemodynamic alterations and endothelial function in young prehypertensive medical students; 2. to examine the possbility to improve these haemodynamic changes after exposure to an endothelial dependent (salbutamol) and…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference between prehypertensive and normotensive subjects in
augmentation index
Secondary outcome
The difference between prehypertensive and normotensive subjects in:
- Pulse wave velocity
- Central aortic blood pressure
- Systemic vascular resistance (SVR)
- Vascular changes (AIx and SVR) after single stimulation with salbutamol and
nitroglycerin
- Endothelial function as assessed with endopat2000
- Correlation between these parameters
Background summary
Prehypertension (or high-normal blood pressure) is commonly defined as a blood
pressure of 130-139/85-89 mmHg and associated with an increased risk of future
hypertension and cardiovascular disease. Hypertension is associated with
functional and structural changes of conduit arteries and endothelial
dysfunction. Compared to normotensive persons hypertensive subjects have a
two-fold increase in arterial stiffness. Pulse wave velocity (PWV) and
augmentation index (AIx), both measures of arterial stiffness, are elevated in
patients with hypertension. Information about haemodynamic properties and
endothelial function in prehypertensive subjects is scarce. Compared to
normotensive subjects, arterial stiffness is augmented in prehypertensive
patients. Endothelial dysfunction has been demonstrated in hypertensive
individuals and normotensive offspring of hypertensive parents. The presence of
increased augmentation, its possible improvement after exposure to
nitroglycerin and salbutamol and its association with arterial stifness,
systemic vascular rsistance (SVR) and endothelial dysfunction in
prehypertensive persons has not been assessed.
Study objective
1. to investigate early haemodynamic alterations and endothelial function in
young prehypertensive medical students;
2. to examine the possbility to improve these haemodynamic changes after
exposure to an endothelial dependent (salbutamol) and endothelium independent
stimulation
3. the correlation between augmentation of the pulse wave, arterial stiffness,
SVR and endothelial dysfunction in normotensive and prehypertensive subjects.
Study design
Cross-sectional case-control study
Study burden and risks
Prehypertension can be considered an early stage of hypertension and is already
associated with an increased CV risk. Therefore, prehypertension provides an
excellent model to study early changes implicated in the development of
hypertension and CVD. Ultimately this may lead to a more tailor made approach
in the identification and treatment of subjects at risk of developing CVD. The
burden for the participants is relatively small, two visits of 15 minutes and
one visit of 2 hours and we do not expect side effects of the two drugs used
for the stimulation test. All assessments are non-invasive, except for one
blood sample. The risks associated with study participation are therefore
negligible.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. willing and able to participate in the study protocol
2. age 18-30 years
3. average blood pressure 130-139/85-89 mmHg
4. blood pressure healthy controls with optimal blood pressure: < 120/80 mmHg
Exclusion criteria
1. history of cardiovascular disease
2. chronic use of prescribed medication
3. any disease requiring chronic treatment by a medical specialist
4. cardiac arrhythmia
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2008-002235-33-NL |
CCMO | NL22971.018.08 |