To study the effect atorvastatin 80mg on (central) sympathetic activity in hypertension patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
sympatisch zenuwstelsel, cardiovasculair (hypertensie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Muscle sympathetic nerve activity (MSNA), HRV, plasma norepinephrine levels,
Secondary outcome
blood pressure and cholesterol levels
Background summary
Sympathoexcitation is an important feature of patients with hypertension. This
sympathoexcitation has demonstrated to have a number of detrimental
side-effects. Current therapy (*-receptor blockade, e.g.) mainly protects
against the increased sympathetic activity in patients with hypertension.
However this approach does not reduce central sympathetic outflow itself. In
animal studies it has been demonstrated that statin therapy does reduce central
sympathetic outflow. We hypothesized that statin therapy reduces central
sympathetic overactivity in hypertension patients.
Study objective
To study the effect atorvastatin 80mg on (central) sympathetic activity in
hypertension patients.
Study design
Double blind-placebo controlled intervention study, cross-over design, single
centre.
Intervention
in a cross-over design all patients will receive 3 weeks treatment with
atorvastatin 80mg daily or placebo. Sympathetic acitivity will be measured
after each treatment period (3 weeks and 6 weeks), using microneurography,
heart rate variability (HRV) and plasma norepinephrine levels. Prior to each
visit ambulatory 24-hour blood pressure monitoring will be performed.
Study burden and risks
Treatment with atorvastatin or placebo is not expected to harm the volunteers.
Most reported side effects of atorvastatin are gastro-intestinal complains and
myalgia. Regarding blood sampling, patients might experience a slight
discomfort during insertion of the catheters and bruising might occur.
Regarding microneurography (MSNA) no major complications have been registered.
According to a study on side-effects of MSNA, 9% of the patients reported
transient paresthesia or local discomfort, which all subsided within 14 days.1
No permanent complications have occurred, not even after numerous (>10)
measurements in one subject. No additional risks should be expected from blood
analysis, no (major) complications have been reported and these techniques have
been used in numerous other experiments. Heart rate variability measurements
add no additional risk to the experiments.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
- Age 18-70 years
- Body mass index 18-35 kg/m2
- hypertension (see protocol)
Exclusion criteria
- renal disease
- recent MI/CVA
- diabete
- diseases of the autonomic nervous system
- any other severe medical condition on the basis of the medical history and a careful physical examination before the study.
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 | EUCTR2007-000310-36-NL |
| CCMO | NL16283.091.07 |