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
1 other identifier
observational
20
1 country
1
Brief Summary
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 16, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJuly 16, 2008
May 1, 2008
1 year
July 14, 2008
July 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Number of (apoptotic) endothelial (progenitor) cells
baseline
Secondary Outcomes (1)
• Oxidative stress: cytosolic and mitochondrial FR
baseline
Study Arms (2)
CHF
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
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.
Eligibility Criteria
Patients admitted to the OLVG hospital for worsening congestive heart failure selected for biventricular pacemaker implantation
You may qualify if:
- 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
You may not qualify if:
- Renal failure (creatinine \> 1.70 mg/dl)
- Signs of infection or inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OLVG Hospital
Amsterdam, North Holland, 1090hm, Netherlands
Related Links
Biospecimen
Bloodsamples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 16, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 16, 2008
Record last verified: 2008-05