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NCT Number: NCT07416279

Can Tiny Bubbles Offer an Alternative to Catheters for Assessing Pressures Inside the Heart? Investigating Ultrasound Contrast Agents as Pressure Sensors Against Gold Standard Catheter Pressures in Cardiac Catheterisation Patients.

The goal of this clinical trial is to investigate if ultrasound contrast agents can be used to estimate filling pressures inside the heart in patients with suspected heart disease. The main questions it aims to answer are:

* Is there a strong correlation between the contrast signal and filling pressures inside the heart? * What is the calibration approach to convert the contrast signal from dB to a measure of pressure in mmHg?

Researchers will compare the contrast signal with reference pressures measured using a catheter to see if it can be used to quantify filling pressures inside the heart.

Participants will:

* Be exposed to a small amount of additional ionising radiation to guide a catheter in position inside the heart for reference pressures * Receive an ultrasound contrast agent at the clinically recommended dose and in line with clinical guidelines, via an intravenous line in their arm * Undergo contrast echocardiography - ultrasound scan of their heart with contrast * Undergo standard echocardiography - ultrasound scan of their heart without contrast

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Key information

Age range

21 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Location status: Recruiting

About this study

This study will record ultrasound contrast signals simultaneously with gold standard catheter pressure measurements inside the heart, to enable a direct comparison between the two methods. Complementary ultrasound data will be used to develop a personalised calibration solution to convert the contrast signal in dB to estimated pressure in mmHg. All study procedures will be completed on the same day as the participant's standard of care cardiac catheterisation and no additional study visits will be required.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast Echocardiography

Other

Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory

Other names: Standard echocardiography, High frame rate contrast echocardiography

Primary outcomes

  1. Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter

    Time frame: 20 minutes

    The ultrasound signal of SonoVue at the subharmonic frequency will be compared with left ventricular filling pressures measured using a high-fidelity catheter.

Secondary outcomes

  1. Intracardiac pressure estimated from the ultrasound signal of SonoVue, converted from dB to mmHg using an ultrasound-based calibration approach

    Time frame: 20 minutes

    The signal of ultrasound contrast agents has to be calibrated to convert it from dB to mmHg for pressure. Ultrasound-based approaches involving standard echocardiography and high frame rate contrast echocardiography will be investigated as potential calibration approaches in this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Nio, PhD

CONTACT

[email protected]

+44 (0)20 7836 5454

Kevin O'Gallagher, MBBS, PhD

CONTACT

kevin.o'[email protected]

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • King's College Hospital NHS Trust

Registry information

Official study title

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

Acronym: SonoHeart

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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