Authorised Therapeutic use (Phase IV) Pulmonary Hypertension

The effect of Oxygen sUppleTion on vascular resistance and FLOW: the OUTFLOW study

EU CTIS ID: 2024-516279-34-00

What this study is testing

To objectify the effect of high-concentration (100%) oxygen suppletion on coronary, pulmonary and systemic haemodynamics, and the chronological sequence of these effects

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • Estimated glomerular filtration rate of <30ml/min
  • Known history of chronic obstructive pulmonary disease GOLD IV
  • Known moderate and severe valvular disease
  • Clinically indicated treatment with oxygen
  • Pacemaker in situ
  • Active pregnancy
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • Estimated glomerular filtration rate of <30ml/min
  • Known history of chronic obstructive pulmonary disease GOLD IV
  • Known moderate and severe valvular disease
  • Clinically indicated treatment with oxygen
  • Pacemaker in situ
  • Active pregnancy
  • Contrast allergy
  • Complications during clinically indicated invasive heart catheterization

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.