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.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 21 Years – 81 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Contrast Echocardiography	Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: United Kingdom