The Effect of Left Ventricular Filling Pressure on Pulmonary Clearance of Free Radical Loaded White Blood Cells and Platelets in Congestive Heart Failure Patients Before and After Biventricular Pacing (OXIS-PACING)
|ClinicalTrials.gov Identifier: NCT00716885|
Recruitment Status : Unknown
Verified May 2008 by VU University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : July 16, 2008
Last Update Posted : July 16, 2008
- 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
- 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
- Interaction of oxidative stress with circulating endothelial progenitor cells (EPCs) and presence of apoptotic endothelial (progenitor) cells
|Condition or disease|
|Congestive Heart Failure|
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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||The Effect of Left Ventricular Filling Pressure on Pulmonary Clearance of Free Radical Loaded White Blood Cells and Platelets in Congestive Heart Failure Patients Before and After Biventricular Pacing|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||September 2009|
Informed consented participants are recruited among all patients admitted to the OLVG hospital.
The control group consists of ten age-matched volunteers with a normal left ventricular ejection fraction and without signs or symptoms of heart failure.
- • Number of (apoptotic) endothelial (progenitor) cells [ Time Frame: baseline ]
- • Oxidative stress: cytosolic and mitochondrial FR [ Time Frame: baseline ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716885
|Contact: Walter J Paulus, Professor||00 31 20 444 firstname.lastname@example.org|
|Contact: Alexander J IJsselmuiden, MD, PhD||00 31 20 444 email@example.com|
|OLVG Hospital||Not yet recruiting|
|Amsterdam, Noord Holland, Netherlands, 1090hm|
|Contact: G. A. Somsen, MD,PhD +31 (0) 20 5993032 firstname.lastname@example.org|