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.
Recruiting
N/AInterventional Study
HFpEF - Heart Failure With Preserved Ejection FractionCardiac CatheterisationHeart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 81
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
10 (estimated)
Sponsor
King's College London · Other
Who this trial is looking for
This trial is looking for patients who need a heart procedure to see if a special ultrasound can help check heart pressures. Participants will receive an ultrasound contrast agent and undergo tests with and without it to compare the results.
Are You a Good Fit for This Trial?
Rules you outRecent acute coronary syndromeUnstable ischaemic cardiac disease
You may be able to join if
I am willing and able to give consent to participate.
I require a cardiac catheterisation procedure as part of my medical care.
I have good acoustic windows for echocardiography when lying flat.
You may not be able to join if
I have a known allergy to SonoVue or its components.
I have a hole in my heart that lets blood bypass the lungs.
I have severe pulmonary hypertension.
I have uncontrolled high blood pressure.
I have adult respiratory distress syndrome.
I am currently using dobutamine or have been advised not to take it.
I have moderate to severe heart valve disease.
I am pregnant or may be pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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
Trial Locations
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Eligibility 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…
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
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