Examine the impact of 7-day daily ischemic preconditioning on brachial artery endothelial function (measured as FMD%) in the dominant arm (i.e. local effect: primary objective) and contra-lateral arm (i.e. remote effect: secondary objective) in…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in endothelial function after a 7-day intervention (measured as the
brachial artery flow-mediated dilation for the primary objective and
contra-lateral brachialartery flow-mediated dilation for the secondary
objective).
Secondary outcome
brachial artery endothelial function in the dominant arm after
ischemia-reperfusion injury
Background summary
The endothelium, i.e. the inner layer of arteries, plays a crucial role in
maintaining vascular integrity and health. Patients with kidney disease
undergoing dialysis demonstrate endothelial dysfunction and it is reported that
brachial artery endothelial function measured as the flow-mediated dilation
(FMD%) has predictive capacity for prognosis. Therefore, improving FMD% seems
to have clinical relevance.
Ischemic preconditioning (IPC) refers to the exposure of tissue to short,
repeated bouts of ischemia. Whilst IPC has protective effects against prolonged
ischemia, we and other recently found the potential of repeated, daily IPC to
improve endothelial function in healthy volunteers. To date, no previous study
examined the potential of repeated, daily IPC to improve endothelial function
in subjects with a priori endothelial dysfunction, such as in subjects with
kidney disease. Furthermore, it is unknown whether repeated, daily IPC can
improve endothelial function in the arm exposed to the IPC-stimulus as well as
distant vascular beds (i.e. remote effect).
Study objective
Examine the impact of 7-day daily ischemic preconditioning on brachial artery
endothelial function (measured as FMD%) in the dominant arm (i.e. local effect:
primary objective) and contra-lateral arm (i.e. remote effect: secondary
objective) in subjects with kidney disease
Study design
Explorative study
Intervention
7 day, daily, unilateral IPC (4X5-minutes of occlusion of the upper arm using a
blood pressure cuff)
Study burden and risks
Measures (FMD and endothelium-independent dilation) and interventions (repeated
IPC) are not associated with any potential health risk. Even in this group of
kidney disease patients undergoing dialysis, we expect no potential health risk
of our measures and interventions.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
• Patients with chronic kidney disease (CKD stage 4 or 5)
Exclusion criteria
• The presence of a patent arterio-venous fistula (for dialysis)
• Simultaneous participation in another interventional study
• Impossibility to perform RIPC, due to pathology of both arms (for example, sclerodermia, dystrophy, recent trauma, chronic wounds)
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 | NL49583.091.14 |