NCT07416279Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 10 Feb 2026
- Start date
- Feb 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- King's College London
- Diseases
- Heart failure
- NCT number
- NCT07416279
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Feb 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known previous allergy to SonoVue, used in ultrasound contrast scans
Other illness
- 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
- Participating in other research that would prolong their cardiac catheterisation procedure, to ensure that the overall process does not become too tiring or burdensome
Other
- 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
Who the study is looking for
- 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
Age in the registry: 21 years to 81 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.