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Clinical trial Recruiting at 1 site Interventional Ages 21 to 81

Tiny ultrasound bubbles as an alternative to catheters for measuring pressures inside the heart

Official title: Intracardiac Pressures From Microbubbles Instead of a Catheter: First in Human Study and Signal Calibration

Run by King's College London · NCT07416279 · Data updated 2026-11-12

This will test whether injecting tiny ultrasound bubbles can estimate heart filling pressures in people who are having a cardiac catheterisation.

More HFpEF - Heart Failure With Preserved Ejection Fraction trials

Quick facts

Study typeInterventional
Ages21 Years to 81 Years
SexAll
Enrollment10 (estimated)
SponsorKing's College London
Academic / other
Drugs / interventionsradiation
Locations1 site (London)
StatusRecruiting
StartedFebruary 2026
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedFebruary 18, 2026
Trial IDNCT07416279 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults who are scheduled to undergo a clinically indicated cardiac catheterisation, can give informed consent, can receive ultrasound contrast, and have good echocardiographic acoustic windows when lying flat.

Probably not a fit

People with known allergy to the contrast agent (SonoVue) or its components, intracardiac right-to-left shunts, severe pulmonary hypertension, uncontrolled high blood pressure, ARDS, or current use of dobutamine would be excluded and therefore would not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will record the ultrasound contrast (microbubble) signal at the same time as gold-standard catheter pressure measurements during patients' routine cardiac catheterisation. They will compare the microbubble subharmonic signal with intracardiac pressures and develop a personalised calibration to convert the signal (dB) into pressure (mmHg). All procedures occur on the same day as the standard-of-care catheterisation, with contrast given intravenously and a small amount of additional X-ray exposure to guide the catheter. No extra follow-up visits are required beyond the usual clinical care.

Why it matters

Potential benefit: If successful, this could allow clinicians to estimate intracardiac filling pressures noninvasively using contrast echocardiography, reducing reliance on invasive catheter measurements.

How similar studies have gone: Early laboratory work and small pilot human studies have suggested microbubble subharmonic signals can reflect pressure changes, but the method is not yet established in routine clinical practice.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant is willing and able to give informed consent to participate in the study
* Patients who require a cardiac catheterisation procedure as part of their standard medical care
* Good acoustic windows for echocardiography when lying flat on their back

Exclusion Criteria:

* Known previous allergy to SonoVue, used in ultrasound contrast scans
* Known allergy to any of the components of SonoVue microbubbles, for example, sulphur hexafluoride or polyethylene glycol (PEG), also known as macrogol, which is in bowel preparations used during colonoscopy and certain laxatives
* A hole in their heart that lets blood flow from the right side to the left, skipping the lungs
* Very high blood pressure in the arteries of the lungs (severe pulmonary hypertension)
* Uncontrolled high blood pressure (hypertension)
* Adult respiratory distress syndrome (ARDS; where severe lung inflammation prevents enough oxygen from reaching the body)
* Current use of the medicine dobutamine (used to treat heart failure), or have been advised not to take dobutamine
* Moderate to severe heart valve disease that could affect the catheter measurements
* Recent acute coronary syndrome or unstable ischaemic cardiac disease, where blood flow to the heart muscle is reduced
* Pregnant or may be pregnant
* Participation in a clinical trial of a medicine within the past four months, to avoid any possible interactions with SonoVue
* Participating in other research that would prolong their cardiac catheterisation procedure, to ensure that the overall process does not become too tiring or burdensome

Where it's running

  • King's College Hospital
    London, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.