CompletedEarly Phase 1

The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

United States28 participantsStarted 2020-08-12

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Critical illness severe enough to preclude extended cardiac catheterization time
. Patients already on vasopressin
. Patients with pulmonary hypertension.
. Patient not scheduled for cardiac catheterization at Lucile Packard Children's Hospital (LPCH).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in systemic (aortic) blood pressure

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Change in pulmonary artery pressure

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Change in transpulmonary gradient

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

PVR/SVR Ratio

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Trial details

NCT IDNCT04463394

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-15

View on ClinicalTrials.gov More Hypotension trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Critical illness severe enough to preclude extended cardiac catheterization time
. Patients already on vasopressin
. Patients with pulmonary hypertension.
. Patient not scheduled for cardiac catheterization at Lucile Packard Children's Hospital (LPCH).

What they're measuring

Change in systemic (aortic) blood pressure

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Change in pulmonary artery pressure

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Change in transpulmonary gradient

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

PVR/SVR Ratio

Timeframe: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)