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)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
- 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 |
|---|
|
Congestive Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- • Number of (apoptotic) endothelial (progenitor) cells [ Time Frame: baseline ] [ Designated as safety issue: No ]
- • Oxidative stress: cytosolic and mitochondrial FR [ Time Frame: baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Bloodsamples
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
CHF
Informed consented participants are recruited among all patients admitted to the OLVG hospital. Inclusion criteria:
Exclusion criteria:
|
|
Control
The control group consists of ten age-matched volunteers with a normal left ventricular ejection fraction and without signs or symptoms of heart failure.
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients admitted to the OLVG hospital for worsening congestive heart failure selected for biventricular pacemaker implantation
Patient selection
Informed consented participants are recruited among all patients admitted to the OLVG hospital.
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
Contacts and Locations| Contact: Walter J Paulus, Professor | 00 31 20 444 8110 | wj.paulus@vumc.nl |
| Contact: Alexander J IJsselmuiden, MD, PhD | 00 31 20 444 8110 | ijsselmuiden@vumc.nl |
| Netherlands | |
| OLVG Hospital | Not yet recruiting |
| Amsterdam, Noord Holland, Netherlands, 1090hm | |
| Contact: G. A. Somsen, MD,PhD +31 (0) 20 5993032 g.a.somsen@olvg.nl | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Professor dr. Walter J. Paulus, VU University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00716885 History of Changes |
| Other Study ID Numbers: | 1781 |
| Study First Received: | July 14, 2008 |
| Last Updated: | July 14, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by VU University Medical Center:
|
Heart failure Oxidative stress Endothelial Progenitor Cells White blood cells |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013