The main objective of this pilot study is to determine the effects of vascular access construction on autonomic and cardiac function.
ID
Source
Brief title
Condition
- Heart failures
- Renal disorders (excl nephropathies)
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Autonomic function
o The following measurements are made in rest:
o heart rate variability (HRV),
o blood pressure variability (BPV) and
o baroreflex sensitivity (BRS).
o Respiratory sinus arrhythmia (RSA) is determined during the deep breathing
test.
o During the vasalva manoeuvre the following measurements are made:
o vasalva ratio (VR) and
o blood pressure respons to the vasalva manoeuvre.
o Blood pressure and heart rate response to the supine-to-stand-test.
Secondary outcome
- Cardiac function measured using echocardiography
- Blood serum levels of several heart markers
- Score on the Hand Ischemic Questionnaire (HIQ).
- Score on the Minnesota living with heart failure questionnaire (Minnesota).
- Successful AVF maturation
- Mortality
- Morbidity
Background summary
Heart failure is a commonly occurring complication in haemodialysis (HD)
patients who have an arteriovenous fistula (AVF)(1-3). It is unknown whether a
*portion* of the heart failure is caused by the extra burden of an open AVF. It
is reasonable to suggest that the hemodynamic effects of an AVF with a large
flow (HFA, high flow acces, > 2 L/min access flow) are greater compared to a
small flow AVF.
The number of diagnostic tools quantifying the systemic hemodynamic
effects of an AVF on cardiac capacity are limited. Some have suggested that the
effect of manually compressing the AVF may provide important information. If
the AVF is occluded, a baroreflex mediated bradycardia is supposed to occur if
the fistula indeed has a significant contribution to systemic hemodynamics.
Interestingly, we have recently found that both patients with a normal
flow AVF and with a HFA showed a significant decrease in heart rate after
manual AVF occlusion. In contrast, only HFA patients demonstrated a significant
increase in both systolic and diastolic blood pressure after AVF occlusion
whereas patients with normal flow AVF*s did not. Findings of our study suggest
that baroreflex function is disturbed in HFA patients (but not in normal flow
patients) as they do not sufficiently adapt to the increased blood pressure by
lowering the heart rate.
We hypothesise that autonomic function is negatively influenced by an AVF.
This mechanism may possibly contribute to an excess mortality risk in HD
patients.
Study objective
The main objective of this pilot study is to determine the effects of vascular
access construction on autonomic and cardiac function.
Study design
An pilot study will be conducted to evaluate the effect of AVF construction on
short term cardiac and autonomic function.
Study burden and risks
The burden of participation is minor as patients are examined three times in
six months while lying on a bed. Only a small of blood is drawn. Unfortunately
the patients may suffer a vasovagal collaps during one of the tests.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
All patients with chronic kidney disease (CKD) stage five who are in a pre-dialysis course and planned for an AVF construction are included in the intervention group.
Exclusion criteria
1. chronic atrial fibrillation or
2. frequent ventricular premature beats,
3. grade III or IV heart failure (according to the NYHA),
4. with permanent pacemakers,
5. previous vascular access (AVF, graft or venous-catheter) or PD catheter,
6. impaired mental capacity or language barrier.
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 | NL39052.015.12 |