NCT01376635

Brief Summary

Background/Aims: To evaluate the sympathovagal balance in patients with chronic kidney disease (CKD) on conservative treatment. Methods: In a cross-sectional study, patients with CKD stages 3, 4 and 5 not yet on dialysis (CKD group) and age-matched healthy subjects (CON group) underwent continuous heart rate recording during two twenty-minute periods in the supine position (pre-inclined), followed by passive postural inclination at 70° (inclined period). Power spectral analysis of the heart rate variability was used to assess the normalized low frequency (LFnu), indicative of sympathetic activity, and the normalized high frequency (HFnu), indicative of parasympathetic activity. The LFnu/HFnu ratio represented sympathovagal balance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

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

May 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
Last Updated

June 20, 2011

Status Verified

May 1, 2008

First QC Date

June 2, 2011

Last Update Submit

June 17, 2011

Conditions

Keywords

Chronic Kidney DiseaseAutonomic Dysfunction

Eligibility Criteria

Age44 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with CKD stages 3, 4 and 5 not yet on dialysis (CKD group) and age-matched healthy subjects (CON group)

You may qualify if:

  • We evaluated 32 individuals (18 men and 14 women) with CKD at stages 3, 4 or 5 who were not yet on dialysis

You may not qualify if:

  • Patients with severe cardiac disease, cancer, diabetes, collagen and demyelinating diseases, left ventricular systolic dysfunction, or a history of stroke were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicPrimary Dysautonomias

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAutonomic Nervous System DiseasesNervous System Diseases

Study Officials

  • Oliveira A Carlos, MD

    Core Educational Research and Treatment in Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 20, 2011

Study Start

May 1, 2008

Study Completion

May 1, 2009

Last Updated

June 20, 2011

Record last verified: 2008-05