2024-516279-34-00Not yet recruitingPhase 4
The effect of Oxygen sUppleTion on vascular resistance and FLOW: the OUTFLOW study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To objectify the effect of high-concentration (100%) oxygen suppletion on coronary, pulmonary and systemic haemodynamics, and the chronological sequence of these effects
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 1 Oct 2024
- Lead sponsor
- Stichting Radboud universitair medisch centrum
- Diseases
- Heart failure
- EU CT number
- 2024-516279-34-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 24
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are already planned for a heart or lung pressure test or a coronary function test, and who have no blocked heart arteries. It studies how extra oxygen changes blood flow.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Planned for a clinically indicated test for small-vessel heart problems, suspected pulmonary hypertension, or heart transplant or LVAD screening. No obstructive coronary artery disease (50% or less visible narrowing, or a negative FFR/iFR/RFR test).
Main reasons for not taking part
- Estimated glomerular filtration rate below 30 ml/min
- Known COPD GOLD IV
- Known moderate or severe valve disease
- Clinically indicated oxygen treatment
- Pacemaker, active pregnancy or contrast allergy
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically indicated treatment with oxygen
Other illness
- Known history of chronic obstructive pulmonary disease GOLD IV
- Known moderate and severe valvular disease
- Contrast allergy
- Complications during clinically indicated invasive heart catheterization
Other
- Estimated glomerular filtration rate of <30ml/min
- Pacemaker in situ
- Active pregnancy
Who the study is looking for
- Subject ≥18 years of age
- Subject planned for clinically indicated: 1. CFT demonstrating microvascular dysfunction; or 2. RHC (and LHC) for suspected PH; or 3. RHC (and LHC) as a part of HTx or LVAD screening
- No obstructive coronary artery disease (defined as ≤50% visual stenosis and/or negative FFR/iFR/RFR)
- Able and willing to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stichting Radboud Universitair Medisch Centrum | Nijmegen | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.