Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005353
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Cardiac Autonomic Control in Children of HIV Positive Mothers
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
The magnitude of clinical problems associated with autonomic dysfunction in children with symptomatic HIV infection is great Hemodynamic abnormalities dysrhythmias unexplained arrest andor 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL048012 | NIH | None | httpsreporternihgovquickSearchR01HL048012 |