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NCT04463394

The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

Completed EARLY_PHASE1 Last updated 14 May 2025
What this trial tests

EARLY_PHASE1 trial testing Vasopressin in Hypotension in 28 participants. Completed in 15 February 2022.

Timeline
12 August 2020
Primary endpoint
15 February 2022
15 February 2022

Quick facts

Lead sponsorStanford University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment28
Start date12 August 2020
Primary completion15 February 2022
Estimated completion15 February 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

Eligibility, any sex, with Hypotension or Fontan Physiology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this study is to evaluate if vasopressin can elevate systemic arterial blood pressures without having a significant effect on pulmonary arterial pressures. Because patients who have undergone Fontan procedures rely on low pressures across the pulmonary vascular bed to maintain cardiac output, vasoactive agents that concomitantly increase systemic and pulmonary pressures may have a deleterious effect in this specific patient population. Hypothesis: In patients with Fontan physiology, vasopressin will increase systemic BP by 20% above baseline, without increasing the transpulmonary gradient.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Acute Hemodynamics in the Fontan Circulation: Open-Label Study of Vasopressin.
    Adamson GT, Yu J, Ramamoorthy C, Peng LF, et al · · 2023 · cited 5× · PMID 37462430 · DOI 10.1097/pcc.0000000000003326

Verify or expand the search:

Other trials of Vasopressin

Trials testing the same drug.

Other recruiting trials for Hypotension

Currently open trials in the same condition.

Other Stanford University trials

Trials by the same sponsor.

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Data sources for this page

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/NCT04463394.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing