Cardiac Autonomic Control in Children of HIV Positive Mothers

NCT ID: NCT00005353

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 1992-06-30
• Study Completion Date: 1995-05-31

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.

Detailed Description

BACKGROUND:

The magnitude of clinical problems associated with autonomic dysfunction in children with symptomatic HIV infection is great. Hemodynamic abnormalities, dysrhythmias, unexplained arrest and/or sudden death are common in HIV positive children, especially when acute deterioration, interventions or neurologic involvement is present. If cardiac dysautonomia is predictive of adverse outcomes in HIV infected children, then a future prospective trial of beta-adrenergic antagonist therapy may be warranted.

DESIGN NARRATIVE:

An analysis was performed on data collected under the NHLBI-sponsored multicenter study entitled 'Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted Human Immunodeficiency Virus (HIV) Infection' and abbreviated P2C2. The P2C2 study was performed in a prospectively defined cohort of 150 children with HIV infection and 350 uninfected control children born to HIV infected women who had been followed since the first month of life to provide understanding of cardiac dysautonomia in early HIV infection. In addition, 198 children with symptomatic HIV infection were analyzed to provide an assessment of cardiac dysautonomia in later stages of pediatric HIV infection. Heart rate spectral analyses were performed on 2196 Holter monitor recordings from these patients followed at the five P2C2 clinical centers to capture noninvasively the time varying contributions of the sympathetic and parasympathetic nervous system to the control of heart rate throughout the course of a day. The spectral balance parameters and the changing response of heart rate to the electrocardiogram-derived respiratory signal characterized the responsiveness of the sympathetic and parasympathetic nervous system at rest and during the events of a normal day. Autonomic function data were electronically transmitted to the P2C2 data coordinating center at the Cleveland Clinic and analyzed along with other P2C2 data (eg. infectious, immunologic, growth, renal, neuroendocrine, pulmonary and cardiac) to determine their risk factor potential for cardiac dysautonomia.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Conditions

Acquired Immunodeficiency Syndrome; Arrhythmia; Heart Diseases; HIV Infections

Eligibility Criteria

Inclusion Criteria

No eligibility criteria

• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

References

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Reference Type: BACKGROUND

PMID: 7921117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7931874 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 4159422 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 8910936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7568644 (View on PubMed)

Other Identifiers

R01HL048012

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4236

Identifier Type: -

Identifier Source: org_study_id