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Trial record 9 of 834 for:    Texas Children's Hospital | ( Map: United States )

Cardiac Biomarkers in Patients With Single Ventricle Physiology

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ClinicalTrials.gov Identifier: NCT03678909
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Marc Anders, Baylor College of Medicine

Brief Summary:

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.


Condition or disease Intervention/treatment
Hypoplastic Left Heart Congenital Heart Disease Cyanotic Congenital Heart Disease Cardiac Disease Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Detailed Description:

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Biomarkers in Patients With Single Ventricle Physiology
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : May 30, 2020


Group/Cohort Intervention/treatment
Hypoplastic Left Heart Disease
Patients with congenital hypoplastic left heart disease who will undergo surgical palliation with Norwood procedure or DKS or Damus-Kaye-Stansel procedure
Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
Norwood Palliation / DKS / Damus-Kaye-Stansel procedure




Primary Outcome Measures :
  1. Mortality [ Time Frame: 3- 6 months depending on second stage procedure ]
    Mortality up to anticipated Glenn Procedure


Secondary Outcome Measures :
  1. NEC [ Time Frame: 3- 6 months depending on second stage procedure ]
    Incidence of Necrotizing enterocolitis

  2. Reintubation [ Time Frame: 3- 6 months depending on second stage procedure ]
    Incidence of Reintubation

  3. Cath intervention [ Time Frame: 3- 6 months depending on second stage procedure ]
    Incidence of cath interventions



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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonate with Hypoplastic Left Heart Syndrome
Criteria

Inclusion Criteria:

Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

Exclusion Criteria:

Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678909


Contacts
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Contact: Marc M Anders, MD 832-824-1000 marc.anders@bcm.edu

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Marc M Anders, MD    832-824-1000    marc.anders@bcm.edu   
Principal Investigator: Raysa C Morales Demori         
Principal Investigator: Jeffrey S Heinle         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Marc M Anders, ND Baylor College of Medicine

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Responsible Party: Marc Anders, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03678909     History of Changes
Other Study ID Numbers: H-42776
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data is blinded to other study investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marc Anders, Baylor College of Medicine:
Troponin
BNP
Biomarkers
Hypoplastic Left Heart
Norwood
DKS

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities