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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.

Sponsor: King's College London

NCT ID: NCT07416279

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Contrast Echocardiography (other)
How long the study runs
Study runs about 13 months (dates as stated)
About the drug or intervention
Contrast Echocardiography — other: Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
21 Years to 81 Years
Who
All
Number of participants
10
Started
2026-02
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for hfpef - heart failure with preserved ejection fraction
  • • NA - 10 participants
  • • 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

Who can take part?

  • • Ages 21 Years to 81 Years
  • • Diagnosed with hfpef - heart failure with preserved ejection fraction

Where?

  • • London - King's College Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

HFpEF - Heart Failure With Preserved Ejection FractionCardiac CatheterisationHeart Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 21 Years - 81 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a cardiac catheterisation procedure as part of their standard medical care

What the study is looking for

  • ✓Participant is willing and able to give agreement to take part to participate in the study
  • ✓Patients who require a heart catheterisation procedure as part of their standard medical care
  • ✓Good acoustic windows for echocardiography when lying flat on their back

Who cannot take part

  • ✗Known previous allergy to SonoVue, used in ultrasound contrast scans
  • ✗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 lung hypertension)
  • ✗Uncontrolled high blood pressure (hypertension)
  • ✗Adult respiratory distress syndrome (ARDS; where severe lung inflammation prevents enough oxygen from reaching the body)
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 Is This Study? (1 UK site)

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

How to Get in Touch

Amanda Nio, PhD

Sponsor contact

CONTACT

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

Kevin O'Gallagher, MBBS, PhD

Sponsor contact

CONTACT

kevin.o'gallagher@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02