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

NCT ID: NCT00716885

Last Updated: 2008-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Congestive Heart Failure

Keywords

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Heart failure Oxidative stress Endothelial Progenitor Cells White blood cells

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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VU University Medical Center

Locations

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OLVG Hospital

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Walter J Paulus, Professor

Role: CONTACT

Phone: 00 31 20 444 8110

Email: [email protected]

Alexander J IJsselmuiden, MD, PhD

Role: CONTACT

Phone: 00 31 20 444 8110

Email: [email protected]

Facility Contacts

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G. A. Somsen, MD,PhD

Role: primary

Related Links

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http://www.vcmo.nl

United Committee Human Research (the Netherlands)

Other Identifiers

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1781

Identifier Type: -

Identifier Source: org_study_id