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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-18

No results posted yet for this study

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

Interventions

OTHER

Contrast Echocardiography

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416279 on ClinicalTrials.gov