1) To assess whether a correlation exist between the degree of pulmonary clearance of free radical positive white bloodcells and platelets and the degree of pulmonary congestion in congestive heart failure (CHF) patients2) To asses whether cardiac…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
·Oxidative stress: cytosolic and mitochondrial FR
Bloodsamples are incubated with a fluorescent CM-DCF probe, which detects
cytosolic FR, or with a Mito-FR probe, which detects mitochondrial FR.
WBCs and platelets with significant fluorescence are identified by FACS and
reported relative to their total number.
·Number of (apoptotic) endothelial (progenitor) cells
LV filling pressure determined by invasive measurement at the time of
biventricular pacemaker implantation
Secondary outcome
see figure 2 en pag. 16 protocol
Background summary
Evidence exists that oxidative stress is enhanced in congestive heart
failure patients resulting in damage to cellular lipids, proteins and DNA.
Because of free radical-induced apoptosis of skeletal muscle fibers, oxidative
stress is an important contributor to skeletal muscle fatigue and low exercise
tolerance of congestive heart failure patients. Enhanced oxidative stress in
congestive heart failure can exert negative inotropic effects and can have
important effects on the structure and function of the myocardium, and may be
implicated in the progression of congestive heart failure. Free radical stress
could also impair recruitment and differentiation of circulating endothelial
progenitor cells resulting in increased all cause mortality.
Reduced pulmonary clearance of free radical loaded white blood cells and
platelets is an important contributor to enhanced oxidative stress in
congestive heart failure patients. Failure of pulmonary clearance of free
radical loaded white blood cells and platelets probably results from pulmonary
congestion which has led to the rationale of the current study. Biventricular
pacing for resynchronization therapy in congestive heart failure patients
reduces left ventricular filling pressure and pulmonary congestion.
Biventricular pacing may therefore augment pulmonary clearance of free radical
loaded white blood cells and platelets in congestive heart failure patients.
We conduct a prospective, observational clinical study to investigate the
correlation of left ventricular filling pressure, pulmonary clearance of FR
loaded circulating white blood cells and platelets and number of endothelial
progenitor cells in congestive heart failure (CHF) patients before and after
implantation of a biventricular pacemaker for resynchronization therapy.
Study objective
1) To assess whether a correlation exist between the degree of pulmonary
clearance of free radical positive white bloodcells and platelets and the
degree of pulmonary congestion in congestive heart failure (CHF) patients
2) To asses whether cardiac resynchronization therapy improves pulmonary
clearance of free radical positive white blood cells and platelets in CHF
patients by alleviating pulmonary congestion
3) Interaction of oxidative stress with circulating endothelial progenitor
cells (EPCs) and presence of apoptotic endothelial (progenitor) cells
Study design
See protocol
Study burden and risks
Time investiment for the patient (1/2 a day for follow up)
Very small risk for heamatoma after blood withdrawel.
Met name tijdsbelasting voor patient (1/2 dag terugkomen voor follow-up).
Zeer kleine kans op de vorming van een hematoom a.g.v. bloedafname tijdens
follow-up.
van der boechhorststraat 7
1081 BT Amsterdam
Nederland
van der boechhorststraat 7
1081 BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
·Chronic congestive heart failure patients of all ages selected for biventricular pacemaker implantation for resynchronization therapy
·Dyspnoe NYHA class III and IV
·Optimal and constant heart failure treatment according to the ESC guidelines
Exclusion criteria
·Renal failure (creatinine >1.70 mg/dl)
·Signs of infection or inflammation
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 |
|---|---|
| ClinicalTrials.gov | NCT00716885 |
| CCMO | NL21219.067.08 |