NCT00716885

Brief Summary

  1. 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. 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. 3.Interaction of oxidative stress with circulating endothelial progenitor cells (EPCs) and presence of apoptotic endothelial (progenitor) cells

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 16, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

July 14, 2008

Last Update Submit

July 14, 2008

Conditions

Keywords

Heart failureOxidative stressEndothelial Progenitor CellsWhite blood cells

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodsamples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Walter J Paulus, Professor

CONTACT

Alexander J IJsselmuiden, MD, PhD

CONTACT

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

Locations