NCT00005353

Brief Summary

To establish the incidence, clinical spectrum, and natural history of cardiac dysautonomia as defined by heart rate spectral analysis in both HIV infected and noninfected children and to evaluate the value of heart rate spectral analysis for predicting dysrhythmias and sudden death in infants and children born to HIV infected mothers.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1992

Typical duration 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

June 1, 1992

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1995

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

February 18, 2016

Status Verified

May 1, 2000

First QC Date

May 25, 2000

Last Update Submit

February 17, 2016

Conditions

Acquired Immunodeficiency SyndromeArrhythmiaHeart DiseasesHIV Infections

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (5)

  • Frassica JJ, Orav EJ, Walsh EP, Lipshultz SE. Arrhythmias in children prenatally exposed to cocaine. Arch Pediatr Adolesc Med. 1994 Nov;148(11):1163-9. doi: 10.1001/archpedi.1994.02170110049008.

    PMID: 7921117BACKGROUND

  • Lipshultz SE, Orav EJ, Sanders SP, McIntosh K, Colan SD. Limitations of fractional shortening as an index of contractility in pediatric patients infected with human immunodeficiency virus. J Pediatr. 1994 Oct;125(4):563-70. doi: 10.1016/s0022-3476(94)70008-7.

    PMID: 7931874BACKGROUND

  • Parker J. Stains for strands in sieve tubes. Stain Technol. 1965 Jul;40(4):223-5. doi: 10.3109/10520296509116412. No abstract available.

    PMID: 4159422BACKGROUND

  • Oberlander TF, Berde CB, Saul JP. Halothane and cardiac autonomic control in infants: assessment with quantitative respiratory sinus arrhythmia. Pediatr Res. 1996 Nov;40(5):710-7. doi: 10.1203/00006450-199611000-00010.

    PMID: 8910936BACKGROUND

  • Litvack DA, Oberlander TF, Carney LH, Saul JP. Time and frequency domain methods for heart rate variability analysis: a methodological comparison. Psychophysiology. 1995 Sep;32(5):492-504. doi: 10.1111/j.1469-8986.1995.tb02101.x.

    PMID: 7568644BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeArrhythmias, CardiacHeart DiseasesHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

June 1, 1992

Study Completion

May 1, 1995

Last Updated

February 18, 2016

Record last verified: 2000-05