Last reviewed · How we verify
NCT03404258
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
trial testing Research Blood Sampling in Single-ventricle in 50 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 10 February 2018 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Research Blood Sampling
Conditions studied
- Single-ventricle — all drugs for Single-ventricle →
- Pulmonary Vascular Resistance Abnormality — all drugs for Pulmonary Vascular Resistance Abnormality →
- Superior Cavo-Pulmonary Anastomosis — all drugs for Superior Cavo-Pulmonary Anastomosis →
- Endothelin — all drugs for Endothelin →
Sponsor
University of Colorado, Denver
Who can join
Adults 1 Month to 2, any sex, with Single-ventricle or Pulmonary Vascular Resistance Abnormality. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Proteomic profiling identifies key differences between inter-stage infants with single ventricle heart disease and healthy controls.
Frank BS, Khailova L, Silveira L, Mitchell MB, et al · · 2021 · cited 17× · PMID 33045409 · DOI 10.1016/j.trsl.2020.10.001
Verify or expand the search:
- PubMed search for NCT03404258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Single-ventricle
Currently open trials in the same condition.
- NCT07073612 — Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity · recruiting
- NCT06434207 — Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis · recruiting
- NCT06613477 — PK/PD of Digoxin in Infants With SVHD · Phase 1, PHASE2 · recruiting
- NCT06538571 — Association of Near Infrared Spectroscopy With Interstage Outcomes · NA · recruiting
- NCT06150950 — REHAB Fontan Failure: A Trial of Cardiac Rehabilitation · NA · recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
- NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
- NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
- NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
- NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
- NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03404258 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 11 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03404258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing