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.

NCT07416279 | Recruiting

• 1 other identifier: 331447
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction; Cardiac Catheterisation; Heart Disease

Keywords

Ultrasound contrast agents; Intracardiac filling pressures; Microbubble subharmonic signal; Echocardiography

Outcome Measures

Primary Outcomes (1)

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

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

  20 minutes

Secondary Outcomes (1)

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

  20 minutes

Study Arms (1)

Contrast echocardiography for intracardiac filling pressures

EXPERIMENTAL

Other: Contrast Echocardiography

Interventions

Contrast Echocardiography OTHER

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

Also known as: Standard echocardiography, High frame rate contrast echocardiography

Contrast echocardiography for intracardiac filling pressures

Eligibility Criteria

• Age: 21 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (4)

• Dockerill C, Faraci A, Christensen-Jeffries K, Alastruey J, Rajani R, Lamata P and Nio AQX (2021). SonoVue microbubbles as ultrasound pressure sensors in a dynamic flow phantom. IEEE International Ultrasonics Symposium. doi: 10.1109/IUS52206.2021.9593833

  BACKGROUND

• Smiseth OA, Fernandes JF, Ohte N, Wakami K, Donal E, Remme EW, Lamata P. Imaging-based method to quantify left ventricular diastolic pressures. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1184-1194. doi: 10.1093/ehjci/jeaf017.

  PMID: 39821267 BACKGROUND

• Toulemonde MEG, Corbett R, Papadopoulou V, Chahal N, Li Y, Leow CH, Cosgrove DO, Eckersley RJ, Duncan N, Senior R, Tang MX. High Frame-Rate Contrast Echocardiography: In-Human Demonstration. JACC Cardiovasc Imaging. 2018 Jun;11(6):923-924. doi: 10.1016/j.jcmg.2017.09.011. Epub 2017 Dec 13. No abstract available.

  PMID: 29248652 BACKGROUND

• Nio AQX, Faraci A, Christensen-Jeffries K, Raymond JL, Monaghan MJ, Fuster D, Forsberg F, Eckersley RJ, Lamata P. Optimal Control of SonoVue Microbubbles to Estimate Hydrostatic Pressure. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Mar;67(3):557-567. doi: 10.1109/TUFFC.2019.2948759. Epub 2019 Oct 21.

  PMID: 31634833 BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Amanda Nio, PhD

CONTACT

+44 (0)20 7836 5454; amanda.nio@kcl.ac.uk

Kevin O'Gallagher, MBBS, PhD

CONTACT

kevin.o'gallagher@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)