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.

Recruiting now · Not applicable

Conditions studied: HFpEF - Heart Failure With Preserved Ejection Fraction, Cardiac Catheterisation, Heart Disease

In brief

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

Key facts

Study ID

NCT07416279

Run by

King's College London

People needed

10

Starts

2026-02-01

Expected to finish

2027-03-01

Last updated by the study team

2026-02-18

Who can join

Age: 21 and older, up to 81. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• King's College Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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