Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Biomarkers in Patients With Single Ventricle Physiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678909
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : August 3, 2020
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Biomarkers in Patients With Single Ventricle Physiology
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : July 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Locations
Layout table for location information
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Marc M Anders, ND Baylor College of Medicine
Layout table for additonal information
Responsible Party: Marc Anders, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03678909    
Other Study ID Numbers: H-42776
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data is blinded to other study investigators.

Layout table for additional information
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:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities