SonoHeart
Research type
Research Study
Full title
Intracardiac pressures from microbubbles instead of a catheter: First in human study and signal calibration
IRAS ID
331447
Contact name
Bashir Al-Hashimi
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Background: The heart creates pressure to pump blood throughout the body, which is essential for proper heart function. Measuring this pressure inside the heart is important for diagnosing and managing heart disease. Currently, this is done by inserting a tube (catheter) into the heart, but this can cause bleeding or infection and may not be suitable for frail patients. We are developing a less invasive method that could allow healthcare providers to assess heart pressure using ultrasound contrast agents (small bubbles visible on ultrasound), potentially avoiding the need for a catheter.
Aim: The goal of this study is to test whether ultrasound with SonoVue contrast bubbles can accurately measure heart pressure. We will also explore three non-invasive methods to convert the ultrasound signals into actual pressure measurements.
Study population and location: Patients scheduled for routine heart catheter procedures at King’s College Hospital will be invited to participate. We plan to recruit five men and five women. Patients with medical contraindications to SonoVue or allergies to the ingredients in SonoVue (like sulfur hexafluoride or polyethylene glycol) will not be included.
Methods: A catheter to measure pressure will be inserted into the heart. SonoVue will be given through a drip (IV) in the arm, which is commonly done during ultrasound tests of the heart. We will collect ultrasound images of the bubbles in the heart and compare the signal amplitude (in dB) with the pressure (in mmHg) measured by the catheter. We will test three different ultrasound-based ways to calibrate the bubble signal and convert it to an estimate of intracardiac pressure. All tests will be done while the patient is in cardiac catheterisation laboratory.
REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0787
Date of REC Opinion
28 Jan 2026
REC opinion
Further Information Favourable Opinion