1. To establish the prevalence and prognostic impact of HD-associated LV dysfunction; 2. To identify (clues to) mechanisms/ pathways that are pathophysiologically involved in HD-associated LV function.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of HD-associated LV dysfunction as assessed by pre-, intra-, and
post-HD echocardiography.
Secondary outcome
To elucidate the mechanisms/ pathways that are pathophysiologically involved in
HD-associated LV dysfunction we will relate its occurrence to pre-HD levels and
intra-HD alterations in biomarkers of the inflammatory response (hsCRP, IL-6,
pentraxin III), oxidative stress (SOD, MDA, AGEs), bioincompatibility
(complement, leukocytes), endothelial dysfunction/ activation (von Willebrand
factor), and with autonomic dysfunction (HRV). The choice for these pathways is
based on their likely role in both the regulation of MBF and the increased risk
of adverse cardiac events. Finally, we will evaluate the outcome of this cohort
during a 2-year follow-up and analyse for the prognostic impact of LV
dysfunction on predefined cardiovascular events and changes in LV function by
repeat echocardiography at 1 year and at 2 years.
Background summary
Whereas hemodialysis (HD) is life-saving by replacement of renal function,
there is data to suggest that adverse effects of the HD procedure as such
contribute to the high cardiovascular risk in HD patients. By applying PET
scanning in HD patients, we and others demonstrated that HD sessions elicit
reductions in myocardial blood flow (MBF), even in the absence of
ultrafiltration (UF). Moreover, in some patients the fall in MBF was severe
enough to result in reversible left ventricular (LV) systolic dysfunction
(hypokinesia/ akinesia) in regions with the greatest fall in MBF, indicative of
stunning. In patients with ischemic heart disease, stunning is a strong
predictor of a dismal prognosis. Likewise, repetitive HD-associated myocardial
ischemia of sufficient intensity to result in LV dysfunction might be a
pathogenetic factor in the high cardiovascular morbidity and mortality in HD
patients. HD-associated myocardial ischemia may trigger arrhythmias and
repetitive ischemia may lead to cumulative LV dysfunction and eventually result
in heart failure, a highly prevalent condition in HD patients. The prevalence
of HD-associated LV dysfunction in our HD population is unknown but our data
and those by others suggest it may occur relatively frequent.
Study objective
1. To establish the prevalence and prognostic impact of HD-associated LV
dysfunction;
2. To identify (clues to) mechanisms/ pathways that are pathophysiologically
involved in HD-associated LV function.
Study design
Observational cohort study.
Study burden and risks
The study has limited patient burden. No invasive investigations are performed.
No extra visits are necessary. During a single - regular - HD session, a total
of 4 echocardiographies will be performed immediately before, during, and after
HD. At this single HD session, blood sampling will be done before, during and
after HD. Blood will be sampled from the arterial line of the HD circuit and no
venapunctions are required. During this (single) HD session, a continuous
3-lead ECG-registration will be performed. Skin Auto Fluorescent will be
measured before and after HD by the AGE reader. This is a non-invasive
technique that measures skin autofluorescence on the ventral site of the lower
arm. The procedure takes less than 2 minutes and is not painful.The follow-up
echocardiographies at 1 and 2 years are part of the usual, routine, patient
care.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Adult (age >=18 years old) maintenance hemodialysis patients.
Exclusion criteria
Pre-existing severe (New York Heart Association class IV) left ventricular systolic failure or inadequate echocardiographical windows to obtain images of sufficient quality.
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 | NL26298.042.08 |