Heart Disease Trial, Recruiting NCT04471129 Sponsor: University Hospital, Rouen Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT04471129
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be an adult (18 years or older)
  • You must have had heart surgery using a heart-lung bypass machine more than 24 hours ago, and have had your breathing tube removed for at least 6 hours
  • You must have had a weak heart (with the heart pumping less than 40% of its capacity) before your surgery
  • You must have special monitoring lines in place — one in the lung artery and one in the wrist artery — that are already being used as part of your care
  • You must currently be receiving standard oxygen through a mask or tube, with no increase in oxygen flow needed in the last 30 minutes, and your oxygen levels must be stable (92% or above)
  • Your blood pressure, heart function measurements, and lung pressure must have been stable for the last 30 minutes, with no recent increases in heart-supporting medications
  • Your oxygen flow rate must be 6 litres per minute or less
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the time of joining
  • You must have read and understood the information about the trial and signed a consent form
  • You must be covered by a social security (health insurance) scheme

Who may not be able to join:

  • You have a medical reason why you cannot use non-invasive breathing support or high-flow oxygen therapy (confirm with trial site)
  • You currently have a breathing tube in your throat or a surgical airway opening in your neck
  • Your kidneys are failing and you are on dialysis or a blood-filtering machine
  • Your blood pressure or heart function is dangerously low, or you require high doses of certain heart-supporting medications (confirm with trial site)
  • You are showing signs of serious breathing difficulty, such as breathing very fast, struggling to breathe, or having low oxygen levels
  • You have a serious long-term lung or breathing disease
  • You already use a breathing support machine (NIV or CPAP) at home
  • You have a significant heart valve problem (aortic or mitral valve) that has not been surgically treated (confirm with trial site)
  • You have received certain water-removing medications (loop diuretics) by injection within the last 3 hours, or by mouth within the last 6 hours
  • You are confused, have altered consciousness, or are showing signs of mental confusion (as measured by specific medical tests)
  • You are pregnant, have recently given birth, are breastfeeding, or do not use effective contraception
  • You are under a court order, legal guardianship, or have had your personal freedoms restricted by a legal or administrative decision
  • You are currently taking part in another clinical trial, or have done so in the last 4 weeks, if that trial could affect this one

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University Hospital, Rouen
Registry
ClinicalTrials.gov
Start date
16 September 2020
Est. completion
16 September 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov