HFpEF - Heart Failure With Preserved Ejection FractionSonoHeartNCT07416279
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.
A study testing Contrast Echocardiography in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Cardiac Catheterisation, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 81 years
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction, Cardiac Catheterisation, Heart Disease
- What is being tested?
- Contrast Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin O'Gallagher, MBBS, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
About this study
Official title: Intracardiac Pressures From Microbubbles Instead of a Catheter: First in Human Study and Signal Calibration
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?
Read more
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
Read the 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
- Being tested
- Contrast Echocardiography
- Keywords
- Ultrasound contrast agents, Intracardiac filling pressures, Microbubble subharmonic signal, Echocardiography
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast EchocardiographyOther
Also called Standard echocardiography, High frame rate contrast echocardiography
Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory
| Study group | Role | What they receive |
|---|---|---|
| Contrast echocardiography for intracardiac filling pressures | Experimental | Not described Receives: Other: Contrast Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter
The ultrasound signal of SonoVue at the subharmonic frequency will be compared with left ventricular filling pressures measured using a high-fidelity catheter.
Measured: 20 minutes
Secondary outcomes (1)
Intracardiac pressure estimated from the ultrasound signal of SonoVue, converted from dB to mmHg using an ultrasound-based calibration approach
The signal of ultrasound contrast agents has to be calibrated to convert it from dB to mmHg for pressure. Ultrasound-based approaches involving standard echocardiography and high frame rate contrast echocardiography will be investigated as potential calibration approaches in this study.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416279
- Sponsor's protocol ID
- 331447
- Acronym
- SonoHeart
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data towards any publications and conference papers will be made publicly available on an online open access repository (e.g. Figshare) after the research output is accepted.
Publications
Dockerill C, Faraci A, Christensen-Jeffries K, Alastruey J, Rajani R, Lamata P and Nio AQX (2021). SonoVue microbubbles as ultrasound pressure sensors in a dynamic flow phantom. IEEE International Ultrasonics Symposium. doi: 10.1109/IUS52206.2021.9593833
Smiseth OA, Fernandes JF, Ohte N, Wakami K, Donal E, Remme EW, Lamata P. Imaging-based method to quantify left ventricular diastolic pressures. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1184-1194. doi: 10.1093/ehjci/jeaf017.
PubMed 39821267Toulemonde MEG, Corbett R, Papadopoulou V, Chahal N, Li Y, Leow CH, Cosgrove DO, Eckersley RJ, Duncan N, Senior R, Tang MX. High Frame-Rate Contrast Echocardiography: In-Human Demonstration. JACC Cardiovasc Imaging. 2018 Jun;11(6):923-924. doi: 10.1016/j.jcmg.2017.09.011. Epub 2017 Dec 13. No abstract available.
PubMed 29248652Nio AQX, Faraci A, Christensen-Jeffries K, Raymond JL, Monaghan MJ, Fuster D, Forsberg F, Eckersley RJ, Lamata P. Optimal Control of SonoVue Microbubbles to Estimate Hydrostatic Pressure. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Mar;67(3):557-567. doi: 10.1109/TUFFC.2019.2948759. Epub 2019 Oct 21.
PubMed 31634833
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Pressures From Microbubbles Instead of a Catheter: First in Human Study and Signal Calibration
- ClinicalTrials.gov ID
- NCT07416279
- Acronym / sponsor ID
- SonoHeart / 331447
- Conditions
- HFpEF - Heart Failure With Preserved Ejection Fraction, Cardiac Catheterisation, Heart Disease
- Keywords
- Ultrasound contrast agents, Intracardiac filling pressures, Microbubble subharmonic signal, Echocardiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- Feb 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast echocardiography for intracardiac filling pressures | Experimental | Other: Contrast Echocardiography |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast EchocardiographyAlso: Standard echocardiography, High frame rate contrast echocardiographySimultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory | Other | Contrast echocardiography for intracardiac filling pressures |
Primary outcome
Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter
Time frame: 20 minutes
The ultrasound signal of SonoVue at the subharmonic frequency will be compared with left ventricular filling pressures measured using a high-fidelity catheter.
1 secondary outcome
Intracardiac pressure estimated from the ultrasound signal of SonoVue, converted from dB to mmHg using an ultrasound-based calibration approach
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- BackgroundDockerill C, Faraci A, Christensen-Jeffries K, Alastruey J, Rajani R, Lamata P and Nio AQX (2021). SonoVue microbubbles as ultrasound pressure sensors in a dynamic flow phantom. IEEE International Ultrasonics Symposium. doi: 10.1109/IUS52206.2021.9593833
- Background: PubMed 39821267Smiseth OA, Fernandes JF, Ohte N, Wakami K, Donal E, Remme EW, Lamata P. Imaging-based method to quantify left ventricular diastolic pressures. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1184-1194. doi: 10.1093/ehjci/jeaf017.
- Background: PubMed 29248652Toulemonde MEG, Corbett R, Papadopoulou V, Chahal N, Li Y, Leow CH, Cosgrove DO, Eckersley RJ, Duncan N, Senior R, Tang MX. High Frame-Rate Contrast Echocardiography: In-Human Demonstration. JACC Cardiovasc Imaging. 2018 Jun;11(6):923-924. doi: 10.1016/j.jcmg.2017.09.011. Epub 2017 Dec 13. No abstract available.
- Background: PubMed 31634833Nio AQX, Faraci A, Christensen-Jeffries K, Raymond JL, Monaghan MJ, Fuster D, Forsberg F, Eckersley RJ, Lamata P. Optimal Control of SonoVue Microbubbles to Estimate Hydrostatic Pressure. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Mar;67(3):557-567. doi: 10.1109/TUFFC.2019.2948759. Epub 2019 Oct 21.
- Individual participant dataSharing planned: Yes. De-identified data towards any publications and conference papers will be made publicly available on an online open access repository (e.g. Figshare) after the research output is accepted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin O'Gallagher, MBBS, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Echocardiography in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Cardiac Catheterisation, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Nio, PhD (+44 (0)20 7836 5454, amanda.nio@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07416279, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.