ClinicalTrials.gg
Status unknownNCT00716885OXIS-PACINGUpdated Jul 16, 2008

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

An observational study in Congestive Heart Failure, sponsored by Amsterdam UMC, location VUmc. Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2008-07-16.

Sponsored by Amsterdam UMC, location VUmc · Observational

The sponsor has not verified this record recently (last verified May 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
All
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Study 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
Read the 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.

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Conditions studied

  • Congestive Heart Failure

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Keywords

  • Heart failure
  • Oxidative stress
  • Endothelial Progenitor Cells
  • White blood cells
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In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients admitted to the OLVG hospital for worsening congestive heart failure selected for biventricular pacemaker implantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Patient selection

Informed consented participants are recruited among all patients admitted to the OLVG hospital.

Inclusion criteria

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

Exclusion criteria:

  • Renal failure (creatinine > 1.70 mg/dl)
  • Signs of infection or inflammation
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. • Number of (apoptotic) endothelial (progenitor) cells

    Time frame: baseline

Secondary outcomes

  1. • Oxidative stress: cytosolic and mitochondrial FR

    Time frame: baseline

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Study locations

1 site
  • OLVG Hospital
    Amsterdam, North Holland 1090hm, Netherlands
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00716885
First posted
Jul 16, 2008
Start date
Sep 2008
Primary completion
Sep 2009 (estimated)
Completion
Sep 2009 (estimated)
Last update
Jul 16, 2008

Study contacts

Walter J Paulus, Professor
Contact
wj.paulus@vumc.nl
00 31 20 444 8110
Alexander J IJsselmuiden, MD, PhD
Contact
ijsselmuiden@vumc.nl
00 31 20 444 8110

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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