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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by VU University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00716885
First received: July 14, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose
  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

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

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • • Number of (apoptotic) endothelial (progenitor) cells [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • 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:

  • 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.

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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716885

Contacts
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

Locations
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   
Sponsors and Collaborators
VU University Medical Center
  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 October 16, 2014