First: to determine the technical and logistical feasibility of measuring changes in myocardial perfusion and left ventricular function with gated 13N-NH3 PET before and during HD. Second: to compare changes in myocardial perfusion and left…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome parameters are changes in cardiac output, myocardial contractility,
left ventricular ejection fraction, left ventricular diameter, left ventricular
end-systolic volume, left ventricular end-diastolic volume, left ventricular
myocardial perfusion in ml/min/g and regional wall motions. Data will be
analysed quantitatively and displayed in a 17-segment polar map. Each
individual session will be evaluated for pre- and post-study body weight, total
ultrafiltration volume, blood pressure and the course of relative blood volume
(measured non-invasively by an RBV monitor) throughout the study.
Secondary outcome
n.a.
Background summary
Dialysis induced hypotension is an important complication of the hemodialysis
(HD) treatment. Two factors play a crucial role in the aetiology of HD
hypotension: 1. A decrease in blood volume during HD. 2. The capacity of the
cardiovascular system to respond adequately to this decrease in blood volume.
Patients on renal replacement therapy have a variety of cardiac abnormalities.
Several studies have shown that cardiac output, and myocardial contractility
significantly falls during HD. At present it is not known if this reduction in
cardiac output is primarily caused by a reduction in filling pressure of the
left ventricle, induced by a decrease in venous return in combination with
diastolic dysfunction, or by myocardial ischemia leading to a decrease in
cardiac output through regional wall motion abnormalities. Positron emission
tomography (PET) is an advanced imaging technique that allows precise
quantification of myocardial perfusion, metabolism and volume and function of
the left ventricle.
Study objective
First: to determine the technical and logistical feasibility of measuring
changes in myocardial perfusion and left ventricular function with gated
13N-NH3 PET before and during HD. Second: to compare changes in myocardial
perfusion and left ventricular function before and during hemodialysis.
Study design
Eight HD patients will be recruited to participate in the study. By applying
the protocol first in two HD patients we investigate whether or not it is
technically and logistically feasible to evaluate if changes in cardiac
behaviour during HD can be detected. If this is not feasible, the study will be
terminated. If this is feasible, then in an additional six patients we will
compare changes in myocardial perfusion and left ventricular function before
and during hemodialysis. Patients will undergo three gated 13N-NH3 PET
measurements in order to evaluate if changes in cardiac behaviour during HD can
be detected. The first gated 13N-NH3 PET will be performed 25 minutes prior to
the start of the HD treatment. Ten minutes after the start of HD, the second
scan will be performed. After the 2nd scan, patients will be transferred onto a
normal bed since this is more comfortable. The 3rd and last scan will be
performed 3 hours and 15 minutes after the start of HD. Since intra-vascular
volume depletion is most prominent when one nears the end of the HD treatment,
we, therefore, expect to find the largest difference with baseline in the last
hour of HD.
Study burden and risks
Patients will have to stay 25 minutes longer in the hospital than usual for a
conventional hemodialysis treatment. Two dialysis needles will be inserted in
the arterio-venous fistula, however, these needles should also have been
inserted without participating in this study. Patients will further undergo: 1)
The inconvenience of lying in the PET-camera for 1 hour and 15 minutes for the
first 2 scans, and an additional 40 minutes for the final scan. 2) The total
amount of radiation from the radiopharmaceuticals leads to a radiation exposure
of 3,2 mSv (1200 MegaBecquerel (MBq)) for the whole duration of the study for
each participating hemodialysis patient. Each bolus of 13N-NH3 contains 400
MBq.
Hanzeplein 1
9713 GZ
NL
Hanzeplein 1
9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1) Adult (age equal to/above 18) HD patients who have been treated with HD for at least six months. 2) Patients must have an arterio-venous fistula without recirculation established by Transonic flow measurements.
Exclusion criteria
1. The absence of informed consent (see ethical considerations). 2. The need to perform HD with pre-dilution. 3. Recent haemorrhage. 4. Unstable angina pectoris. 5. History of myocardial infarction. 6. Inability to endure a horizontal position for a longer period of time. 7. Arrhythmia. 8. The use of long-acting nitrates. 9. Left ventricular ejection fraction <= 30%. 10. Diabetes Mellitus. 11. Pregnancy or suspicion hereof.
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 | EUCTR2006-000867-27-NL |
CCMO | NL11063.042.06 |