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Trial record 36 of 580 for:    Recruiting, Not yet recruiting, Available Studies | Superior

ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis

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ClinicalTrials.gov Identifier: NCT03404258
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.

Condition or disease Intervention/treatment
Single-ventricle Pulmonary Vascular Resistance Abnormality Superior Cavo-Pulmonary Anastomosis Endothelin Metabolomics Other: Research Blood Sampling

Detailed Description:

Overall Hypothesis: Endothelin-1 (ET1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vessel resistance leading to decreased pulmonary blood flow in patients undergoing SCPA.

For enrolled patients, collected data will include:

  • 3 mL blood sample (x2) at pre-SCPA catheterization.
  • 3 mL blood samples at 2, 24, and 48 hours post-operative.
  • Urine sample pre-operatively and post-operatively
  • Collection of otherwise-discarded operative tissue sample from the pulmonary artery.
  • Collection of clinical data, demographic data, and results of routine, post-operative hemodynamic monitoring.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study Patients
Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy.
Other: Research Blood Sampling
Blood samples will be collected at specified time points and research assays will be performed.

Control Patients
Infants between 3 months and 12 months of age with no known cardio-pulmonary disease, no active infection, and no known genetic abnormality undergoing elective surgery for a non-cardiac indication.
Other: Research Blood Sampling
Blood samples will be collected at specified time points and research assays will be performed.




Primary Outcome Measures :
  1. Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period. [ Time Frame: 48 hours post-operatively ]
  2. Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period. [ Time Frame: 48 hours post-operatively ]

Secondary Outcome Measures :
  1. Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy. [ Time Frame: 48 hours post-operatively ]
  2. Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy. [ Time Frame: 48 hours post-operatively ]


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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.
Criteria

Inclusion Criteria:

  • Congenital heart disease patients undergoing catheterization for pre-SPCA evaluation or undergoing SCPA without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization).
  • All patients will have age from 31 days to 2 years.

Exclusion Criteria:

  • Patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded.
  • Due to limitations in acceptable sample blood volumes for research, patients with weight <4kg will be excluded.
  • Patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.

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): NCT03404258


Contacts
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Contact: Benjamin Frank, MD 720 777 1954 Benjamin.Frank@childrenscolorado.org
Contact: Jesse Davidson, MD Jesse.Davidson@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Benjamin S Frank, MD    720-777-6820    Benjamin.Frank@childrenscolorado.org   
Contact: Jesse A Davidson, MD    720-777-6820    Jesse.Davidson@childrenscolorado.org   
Principal Investigator: Benjamin S Frank, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Benjamin Frank, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03404258     History of Changes
Other Study ID Numbers: 17-0832
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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