Single-ventricleNCT03404258
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
An observational study of Single-ventricle and Pulmonary Vascular Resistance Abnormality, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Single-ventricle, Pulmonary Vascular Resistance Abnormality, Superior Cavo-Pulmonary Anastomosis
- What is being tested?
- Research Blood Sampling
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- Child
Study population: Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Denver, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Single-ventricle, Pulmonary Vascular Resistance Abnormality, Superior Cavo-Pulmonary Anastomosis, Endothelin, Metabolomics
- Being tested
- Research Blood Sampling
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research Blood SamplingOther
Blood samples will be collected at specified time points and research assays will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Study Patients | Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy. Receives: Other: Research Blood Sampling | |
| 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. Receives: Other: Research Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
Measured: 48 hours post-operatively
Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
Measured: 48 hours post-operatively
Secondary outcomes (2)
Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy.
Measured: 48 hours post-operatively
Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.
Measured: 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start10 Feb 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Frank, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404258
- Sponsor's protocol ID
- 17-0832
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2018
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frank BS, Khailova L, Silveira L, Mitchell MB, Morgan GJ, Hsieh EWY, DiMaria MV, Twite M, Klawitter J, Davidson JA. Proteomic profiling identifies key differences between inter-stage infants with single ventricle heart disease and healthy controls. Transl Res. 2021 Mar;229:24-37. doi: 10.1016/j.trsl.2020.10.001. Epub 2020 Oct 9.
PubMed 33045409
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
- ClinicalTrials.gov ID
- NCT03404258
- Acronym / sponsor ID
- 17-0832
- Conditions
- Single-ventricle, Pulmonary Vascular Resistance Abnormality, Superior Cavo-Pulmonary Anastomosis, Endothelin, Metabolomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Patients | – | Other: Research Blood SamplingInfants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy. |
| Control Patients | – | Other: Research Blood SamplingInfants 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. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research Blood SamplingBlood samples will be collected at specified time points and research assays will be performed. | Other | Control Patients, Study Patients |
Primary outcome
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
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
2 secondary outcomes
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
Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.
Time frame: 48 hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 33045409Frank BS, Khailova L, Silveira L, Mitchell MB, Morgan GJ, Hsieh EWY, DiMaria MV, Twite M, Klawitter J, Davidson JA. Proteomic profiling identifies key differences between inter-stage infants with single ventricle heart disease and healthy controls. Transl Res. 2021 Mar;229:24-37. doi: 10.1016/j.trsl.2020.10.001. Epub 2020 Oct 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Frank, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single-ventricle and Pulmonary Vascular Resistance Abnormality, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.