NCT00794872

Brief Summary

Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the present study is to examine whether chemosensor function is altered in patients with stage 3 and stage 4 CKD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
Last Updated

November 20, 2008

Status Verified

November 1, 2008

Enrollment Period

1.8 years

First QC Date

November 19, 2008

Last Update Submit

November 19, 2008

Conditions

Keywords

Cardiovascular autonomic neuropathyChemoreflex sensitivityChronic kidney diseaseSudden cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease

Study Arms (3)

1

Patients with stage 3 CKD

Other: blood sampling

2

Patients with stage 4 CKD

Other: blood sampling

3

Patients without evidence for CDK

Other: blood sampling

Interventions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from CDK stage 3 (GFR 30-59 ml/min/1.73 m²) or stage 4 (GFR 15-29 ml/min/1.73 m²)
  • For the reference Patients without evidence for CDK

You may not qualify if:

  • Patients with heart failure, history of myocardial infarction or instable angina pectoris, atrial fibrillation, hyperthyroidism, chronic pulmonary diseases, sleep apnoea syndrome, alcohol abuse and drug induced cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Measurement of the venous partial pressure of oxygen in blood samples

MeSH Terms

Conditions

Renal Insufficiency, ChronicDeath, Sudden, Cardiac

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeath

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christian Meyer, MD

    RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 20, 2008

Record last verified: 2008-11

Locations