Heart FailureNCT03854071
Development of Novel Physiological CMR Methods in Health and Disease
A study testing intravenous fluid challenge in people with Heart Failure and Pulmonary Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Physiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Pulmonary Hypertension, Myocardial Infarction
- What is being tested?
- intravenous fluid challenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2018to 1 Jan 2031
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers age 20 to 80, recruited from Sheffield Teaching Hospitals staff members
- Patients age 20 to 80 with suspected or known heart disease (group 1 to 5)
- Capable of giving written informed consent
Who cannot join
- Inability to perform the study protocol secondary to severe heart failure requiring IV therapy
- Patients recruited in the suspected CAD and acute myocardial infarction arms of the study and in need for detection of ischaemia should not have any past medical history of MI, ACS or cardiomyopathy
- Patients with significant valvular heart disease will be excluded from any patient group
- Patient with in atrial fibrillation will be excluded
- Contraindication to MRI (as per standard MRI screening questionnaire issued to patients prior to clinical MRI procedures)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS FT
Sheffield, England, S10 2JF
Sam Walmsley
About this study
Physiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge, pharmacological stressors and physical exercise stress test. Echocardiography, which is the mainstay for the non-invasive rest/stress assessment of the left ventricular (LV) haemodynamics has several limitations. Novel methods of CMR imaging allow to map intra-cardiac flow in three-dimension using novel flow acquisitions. These novel flow acquisitions are called four-dimensional flow CMR, where the fourth dimension is time. Additionally, traditional cine CMR imaging for functional assessment can now be done without breath-holds using advanced acceleration methods, allowing them to be used during exercise. A comprehensive understanding of functional-flow coupling at rest, during increased pre-load (fluid challenge) to the heart or during exercise, is lacking in the literature. There is an important need to validate these novel CMR methods for developing mechanistic insight into physiological cardiac adaptation to increased pre-load or to exercise in health and how it alters in heart disease.
Read the detailed description
For this study, the investigators will perform comprehensive physiological CMR in healthy volunteers and patients with suspected or known heart disease (coronary artery disease and heart failure). A sub-set of patients will have follow-up scans after they receive treatment to investigate the therapeutic target role of these physiological CMR metrics.
Patients who have given informed consent for this research will receive one physiological stress test depending on the clinical context. There will be 5 clinical subgroups to which patients will be recruited to:
Group 1. Heart failure with preserved ejection fraction (HFpEF), Group 2. Heart failure with reserved ejection fraction (HFrEF), Group 3. Pulmonary hypertension (PH), Group 4. Acute myocardial infarction (AMI) and Group 5. Suspected but not treated coronary artery disease (sCAD).
Patients will be selected in each group by the clinical specialist/research team as per the published guidelines and local protocols - Group 1 and 2 (19), Group 3 (20), Group 4 (21) and Group 5 (22).
First 4 groups of patients will receive pre-load increasing stress test (either passive leg raise or equivalent 500mls intravenous fluid challenge depending on the tolerability). This will be done to investigate if increase in pre-load will help unravel subtle dysfunction which is not apparent at euvolemic state. AMI patients may also receive ischaemia testing stress CMR depending on the main clinically question needed to answer. Patients with sCAD will receive clinically relevant pharmacological stress test (dobutamine, adenosine or regadenoson, inhaled nitric oxide) to diagnose ischaemia.
Healthy volunteers who have given informed consent will receive matched physiological stress test so that head-on comparison can be made with the relevant patient cohort. The CMR scan protocol will involve minimal breath-holds and will be patient-friendly. This is achieved by using accelerated, advanced cine and late gadolinium enhancement (LGE)-imaging techniques which require fewer breath-holds and shorter scan. All CMR stress studies will be supervised by an Advanced Life Support (ALS) certified doctor.
The CMR protocol for healthy volunteers will include the following components (45 minutes):
- Survey
- Baseline cine imaging for functional imaging (rest)
- Tissue characterisation with native T1-mapping (rest)
- 4D flow CMR (rest)
- Record blood pressure, heart rate and oxygen saturation
- Start of physiological stress (increase pre-load or pharmacological stressors)
- 4D flow CMR (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Functional cines (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Record blood pressure, heart rate and oxygen saturation
- First pass perfusion imaging (only if adenosine/regadenoson used for myocardial hyperaemia)
- Record blood pressure, heart rate and oxygen saturation
- Gadolinium contrast injection
- Early/Late gadolinium enhancement imaging in short-axis
- Post contrast T1-mapping End of study
For patient's receiving clinical CMR scans, the 'bolt-on' stress CMR protocol will include the following components (20-25minutes):
- 4D flow CMR (rest)
- Record blood pressure, heart rate and oxygen saturation
- Start of physiological stress (increase pre-load or pharmacological stressors)
- 4D flow CMR (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Functional cines (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Record blood pressure, heart rate and oxygen saturation
- First pass perfusion imaging (only if adenosine/regadenoson used for myocardial hyperaemia)
- Record blood pressure, heart rate and oxygen saturation
- Being tested
- intravenous fluid challenge
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary, Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous fluid challengeOther
Patients will undergo a receive a pre-load increasing stress test with intravenous fluids depending on tolerability
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Heart failure patients with preserved ejection fraction Receives: Other: intravenous fluid challenge |
| Group 2 | Other | Heart failure patients with reserved ejection fraction Receives: Other: intravenous fluid challenge |
| Group 3 | Other | Patients with pulmonary hypertension Receives: Other: intravenous fluid challenge |
| Group 4 | Other | Patients with acute myocardial infarction Receives: Other: intravenous fluid challenge |
| Group 5 | Other | Patients with suspected but not treated coronary artery disease Receives: Other: intravenous fluid challenge |
| Group 6 | Other | Healthy Volunteers Receives: Other: intravenous fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
4D CMR Flow
The primary outcome measures will include 4D flow CMR derived mitral inflow diastolic parameter: E/A ratio. This parameter will be quantified once both at rest and during physiological stress.
Measured: Through study completion, average 5 years
Secondary outcomes (2)
Secondary 4D CMR Flow
Other 4D flow CMR derived outcome metrics will include mitral, tricuspid and pulmonary valve flow quantification - net forward flow (mls), E-velocity (cm/sec), E-velocity deceleration time (msec, both for mitral and tricuspid), A-velocity (cm/sec) and valvular regurgitation (mls).
Measured: Through study completion, average 5 years
Volumetric and functional parameters
- Right and left heart volumetric and functional parameters: end-diastolic and end-systolic volumes; ejection fraction
Measured: Through study completion, average 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start30 Jul 2018
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be selected in each group by the clinical specialist/research team as per the published guidelines and local protocols - Group 1, Group 2, Group 3, Group 4 and Group 5.
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854071
- Sponsor's protocol ID
- STH20184
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Obokata M, Kane GC, Reddy YN, Olson TP, Melenovsky V, Borlaug BA. Role of Diastolic Stress Testing in the Evaluation for Heart Failure With Preserved Ejection Fraction: A Simultaneous Invasive-Echocardiographic Study. Circulation. 2017 Feb 28;135(9):825-838. doi: 10.1161/CIRCULATIONAHA.116.024822. Epub 2016 Dec 30.
PubMed 28039229Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
PubMed 27037982Sharifov OF, Schiros CG, Aban I, Denney TS, Gupta H. Diagnostic Accuracy of Tissue Doppler Index E/e' for Evaluating Left Ventricular Filling Pressure and Diastolic Dysfunction/Heart Failure With Preserved Ejection Fraction: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002530. doi: 10.1161/JAHA.115.002530.
PubMed 26811160Franke A. The stress echo dilemma: time counts, but image quality too. Eur Heart J. 2006 Jul;27(14):1646-7. doi: 10.1093/eurheartj/ehl091. Epub 2006 Jun 16. No abstract available.
PubMed 16782718Westenberg JJ, Roes SD, Ajmone Marsan N, Binnendijk NM, Doornbos J, Bax JJ, Reiber JH, de Roos A, van der Geest RJ. Mitral valve and tricuspid valve blood flow: accurate quantification with 3D velocity-encoded MR imaging with retrospective valve tracking. Radiology. 2008 Dec;249(3):792-800. doi: 10.1148/radiol.2492080146. Epub 2008 Oct 10.
PubMed 18849503Crandon S, Elbaz MSM, Westenberg JJM, van der Geest RJ, Plein S, Garg P. Clinical applications of intra-cardiac four-dimensional flow cardiovascular magnetic resonance: A systematic review. Int J Cardiol. 2017 Dec 15;249:486-493. doi: 10.1016/j.ijcard.2017.07.023. Epub 2017 Sep 28.
PubMed 28964555Pedrizzetti G, La Canna G, Alfieri O, Tonti G. The vortex--an early predictor of cardiovascular outcome? Nat Rev Cardiol. 2014 Sep;11(9):545-53. doi: 10.1038/nrcardio.2014.75. Epub 2014 Jun 3.
PubMed 24889521Carlsson M, Toger J, Kanski M, Bloch KM, Stahlberg F, Heiberg E, Arheden H. Quantification and visualization of cardiovascular 4D velocity mapping accelerated with parallel imaging or k-t BLAST: head to head comparison and validation at 1.5 T and 3 T. J Cardiovasc Magn Reson. 2011 Oct 4;13(1):55. doi: 10.1186/1532-429X-13-55.
PubMed 21970399Eriksson J, Bolger AF, Ebbers T, Carlhall CJ. Four-dimensional blood flow-specific markers of LV dysfunction in dilated cardiomyopathy. Eur Heart J Cardiovasc Imaging. 2013 May;14(5):417-24. doi: 10.1093/ehjci/jes159. Epub 2012 Aug 8.
PubMed 22879457Eriksson J, Dyverfeldt P, Engvall J, Bolger AF, Ebbers T, Carlhall CJ. Quantification of presystolic blood flow organization and energetics in the human left ventricle. Am J Physiol Heart Circ Physiol. 2011 Jun;300(6):H2135-41. doi: 10.1152/ajpheart.00993.2010. Epub 2011 Mar 18.
PubMed 21421820Watanabe H, Sugiura S, Hisada T. The looped heart does not save energy by maintaining the momentum of blood flowing in the ventricle. Am J Physiol Heart Circ Physiol. 2008 May;294(5):H2191-6. doi: 10.1152/ajpheart.00041.2008. Epub 2008 Mar 7.
PubMed 18326797Kanski M, Arvidsson PM, Toger J, Borgquist R, Heiberg E, Carlsson M, Arheden H. Left ventricular fluid kinetic energy time curves in heart failure from cardiovascular magnetic resonance 4D flow data. J Cardiovasc Magn Reson. 2015 Dec 20;17:111. doi: 10.1186/s12968-015-0211-4.
PubMed 26685664Wong J, Chabiniok R, deVecchi A, Dedieu N, Sammut E, Schaeffter T, Razavi R. Age-related changes in intraventricular kinetic energy: a physiological or pathological adaptation? Am J Physiol Heart Circ Physiol. 2016 Mar 15;310(6):H747-55. doi: 10.1152/ajpheart.00075.2015. Epub 2016 Jan 8.
PubMed 26747496Ie EH, Vletter WB, ten Cate FJ, Nette RW, Weimar W, Roelandt JR, Zietse R. Preload dependence of new Doppler techniques limits their utility for left ventricular diastolic function assessment in hemodialysis patients. J Am Soc Nephrol. 2003 Jul;14(7):1858-62. doi: 10.1097/01.asn.0000072745.94551.fc.
PubMed 12819246Zhou BY, Xie MX, Wang J, Wang XF, Lv Q, Liu MW, Kong SS, Zhang PY, Liu JF. Relationship between the abnormal diastolic vortex structure and impaired left ventricle filling in patients with hyperthyroidism. Medicine (Baltimore). 2017 Apr;96(17):e6711. doi: 10.1097/MD.0000000000006711.
PubMed 28445281
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Physiological CMR Methods in Health and Disease
- ClinicalTrials.gov ID
- NCT03854071
- Acronym / sponsor ID
- STH20184
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 26 Feb 2019 (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.
Physiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge, pharmacological stressors and physical exercise stress test. Echocardiography, which is the mainstay for the non-invasive rest/stress assessment of the left ventricular (LV) haemodynamics has several limitations. Novel methods of CMR imaging allow to map intra-cardiac flow in three-dimension using novel flow acquisitions. These novel flow acquisitions are called four-dimensional flow CMR, where the fourth dimension is time. Additionally, traditional cine CMR imaging for functional assessment can now be done without breath-holds using advanced acceleration methods, allowing them to be used during exercise. A comprehensive understanding of functional-flow coupling at rest, during increased pre-load (fluid challenge) to the heart or during exercise, is lacking in the literature. There is an important need to validate these novel CMR methods for developing mechanistic insight into physiological cardiac adaptation to increased pre-load or to exercise in health and how it alters in heart disease.
Detailed description
For this study, the investigators will perform comprehensive physiological CMR in healthy volunteers and patients with suspected or known heart disease (coronary artery disease and heart failure). A sub-set of patients will have follow-up scans after they receive treatment to investigate the therapeutic target role of these physiological CMR metrics.
Patients who have given informed consent for this research will receive one physiological stress test depending on the clinical context. There will be 5 clinical subgroups to which patients will be recruited to:
Group 1. Heart failure with preserved ejection fraction (HFpEF), Group 2. Heart failure with reserved ejection fraction (HFrEF), Group 3. Pulmonary hypertension (PH), Group 4. Acute myocardial infarction (AMI) and Group 5. Suspected but not treated coronary artery disease (sCAD).
Patients will be selected in each group by the clinical specialist/research team as per the published guidelines and local protocols - Group 1 and 2 (19), Group 3 (20), Group 4 (21) and Group 5 (22).
First 4 groups of patients will receive pre-load increasing stress test (either passive leg raise or equivalent 500mls intravenous fluid challenge depending on the tolerability). This will be done to investigate if increase in pre-load will help unravel subtle dysfunction which is not apparent at euvolemic state. AMI patients may also receive ischaemia testing stress CMR depending on the main clinically question needed to answer. Patients with sCAD will receive clinically relevant pharmacological stress test (dobutamine, adenosine or regadenoson, inhaled nitric oxide) to diagnose ischaemia.
Healthy volunteers who have given informed consent will receive matched physiological stress test so that head-on comparison can be made with the relevant patient cohort. The CMR scan protocol will involve minimal breath-holds and will be patient-friendly. This is achieved by using accelerated, advanced cine and late gadolinium enhancement (LGE)-imaging techniques which require fewer breath-holds and shorter scan. All CMR stress studies will be supervised by an Advanced Life Support (ALS) certified doctor.
The CMR protocol for healthy volunteers will include the following components (45 minutes):
- Survey
- Baseline cine imaging for functional imaging (rest)
- Tissue characterisation with native T1-mapping (rest)
- 4D flow CMR (rest)
- Record blood pressure, heart rate and oxygen saturation
- Start of physiological stress (increase pre-load or pharmacological stressors)
- 4D flow CMR (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Functional cines (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Record blood pressure, heart rate and oxygen saturation
- First pass perfusion imaging (only if adenosine/regadenoson used for myocardial hyperaemia)
- Record blood pressure, heart rate and oxygen saturation
- Gadolinium contrast injection
- Early/Late gadolinium enhancement imaging in short-axis
- Post contrast T1-mapping End of study
For patient's receiving clinical CMR scans, the 'bolt-on' stress CMR protocol will include the following components (20-25minutes):
- 4D flow CMR (rest)
- Record blood pressure, heart rate and oxygen saturation
- Start of physiological stress (increase pre-load or pharmacological stressors)
- 4D flow CMR (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Functional cines (stress, at low-moderate intensity exercise aiming for heart rate up to 110bpm only)
- Record blood pressure, heart rate and oxygen saturation
- First pass perfusion imaging (only if adenosine/regadenoson used for myocardial hyperaemia)
- Record blood pressure, heart rate and oxygen saturation
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Patients will be selected in each group by the clinical specialist/research team as per the published guidelines and local protocols - Group 1, Group 2, Group 3, Group 4 and Group 5.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: intravenous fluid challengeHeart failure patients with preserved ejection fraction |
| Group 2 | Other | Other: intravenous fluid challengeHeart failure patients with reserved ejection fraction |
| Group 3 | Other | Other: intravenous fluid challengePatients with pulmonary hypertension |
| Group 4 | Other | Other: intravenous fluid challengePatients with acute myocardial infarction |
| Group 5 | Other | Other: intravenous fluid challengePatients with suspected but not treated coronary artery disease |
| Group 6 | Other | Other: intravenous fluid challengeHealthy Volunteers |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Volunteers age 20 to 80, recruited from Sheffield Teaching Hospitals staff members
- Patients age 20 to 80 with suspected or known heart disease (group 1 to 5)
- Capable of giving written informed consent
Key exclusion criteria (5 listed)
- Inability to perform the study protocol secondary to severe heart failure requiring IV therapy
- Patients recruited in the suspected CAD and acute myocardial infarction arms of the study and in need for detection of ischaemia should not have any past medical history of MI, ACS or cardiomyopathy
- Patients with significant valvular heart disease will be excluded from any patient group
- Patient with in atrial fibrillation will be excluded
- Contraindication to MRI (as per standard MRI screening questionnaire issued to patients prior to clinical MRI procedures)
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 |
|---|---|---|
| intravenous fluid challengePatients will undergo a receive a pre-load increasing stress test with intravenous fluids depending on tolerability | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
4D CMR Flow
Time frame: Through study completion, average 5 years
The primary outcome measures will include 4D flow CMR derived mitral inflow diastolic parameter: E/A ratio. This parameter will be quantified once both at rest and during physiological stress.
2 secondary outcomes
Secondary 4D CMR Flow
Time frame: Through study completion, average 5 years
Volumetric and functional parameters
Time frame: Through study completion, average 5 years
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 Mar 2026.
- Background: PubMed 28039229Obokata M, Kane GC, Reddy YN, Olson TP, Melenovsky V, Borlaug BA. Role of Diastolic Stress Testing in the Evaluation for Heart Failure With Preserved Ejection Fraction: A Simultaneous Invasive-Echocardiographic Study. Circulation. 2017 Feb 28;135(9):825-838. doi: 10.1161/CIRCULATIONAHA.116.024822. Epub 2016 Dec 30.
- Background: PubMed 27037982Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
- Background: PubMed 26811160Sharifov OF, Schiros CG, Aban I, Denney TS, Gupta H. Diagnostic Accuracy of Tissue Doppler Index E/e' for Evaluating Left Ventricular Filling Pressure and Diastolic Dysfunction/Heart Failure With Preserved Ejection Fraction: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002530. doi: 10.1161/JAHA.115.002530.
- Background: PubMed 16782718Franke A. The stress echo dilemma: time counts, but image quality too. Eur Heart J. 2006 Jul;27(14):1646-7. doi: 10.1093/eurheartj/ehl091. Epub 2006 Jun 16. No abstract available.
- Background: PubMed 18849503Westenberg JJ, Roes SD, Ajmone Marsan N, Binnendijk NM, Doornbos J, Bax JJ, Reiber JH, de Roos A, van der Geest RJ. Mitral valve and tricuspid valve blood flow: accurate quantification with 3D velocity-encoded MR imaging with retrospective valve tracking. Radiology. 2008 Dec;249(3):792-800. doi: 10.1148/radiol.2492080146. Epub 2008 Oct 10.
- Background: PubMed 28964555Crandon S, Elbaz MSM, Westenberg JJM, van der Geest RJ, Plein S, Garg P. Clinical applications of intra-cardiac four-dimensional flow cardiovascular magnetic resonance: A systematic review. Int J Cardiol. 2017 Dec 15;249:486-493. doi: 10.1016/j.ijcard.2017.07.023. Epub 2017 Sep 28.
- Background: PubMed 24889521Pedrizzetti G, La Canna G, Alfieri O, Tonti G. The vortex--an early predictor of cardiovascular outcome? Nat Rev Cardiol. 2014 Sep;11(9):545-53. doi: 10.1038/nrcardio.2014.75. Epub 2014 Jun 3.
- Background: PubMed 21970399Carlsson M, Toger J, Kanski M, Bloch KM, Stahlberg F, Heiberg E, Arheden H. Quantification and visualization of cardiovascular 4D velocity mapping accelerated with parallel imaging or k-t BLAST: head to head comparison and validation at 1.5 T and 3 T. J Cardiovasc Magn Reson. 2011 Oct 4;13(1):55. doi: 10.1186/1532-429X-13-55.
- Background: PubMed 22879457Eriksson J, Bolger AF, Ebbers T, Carlhall CJ. Four-dimensional blood flow-specific markers of LV dysfunction in dilated cardiomyopathy. Eur Heart J Cardiovasc Imaging. 2013 May;14(5):417-24. doi: 10.1093/ehjci/jes159. Epub 2012 Aug 8.
- Background: PubMed 21421820Eriksson J, Dyverfeldt P, Engvall J, Bolger AF, Ebbers T, Carlhall CJ. Quantification of presystolic blood flow organization and energetics in the human left ventricle. Am J Physiol Heart Circ Physiol. 2011 Jun;300(6):H2135-41. doi: 10.1152/ajpheart.00993.2010. Epub 2011 Mar 18.
- Background: PubMed 18326797Watanabe H, Sugiura S, Hisada T. The looped heart does not save energy by maintaining the momentum of blood flowing in the ventricle. Am J Physiol Heart Circ Physiol. 2008 May;294(5):H2191-6. doi: 10.1152/ajpheart.00041.2008. Epub 2008 Mar 7.
- Background: PubMed 26685664Kanski M, Arvidsson PM, Toger J, Borgquist R, Heiberg E, Carlsson M, Arheden H. Left ventricular fluid kinetic energy time curves in heart failure from cardiovascular magnetic resonance 4D flow data. J Cardiovasc Magn Reson. 2015 Dec 20;17:111. doi: 10.1186/s12968-015-0211-4.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous fluid challenge in people with Heart Failure and Pulmonary Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 5 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 Mar 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 Helen Denney (0114 2269047, H.Denney@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4D CMR Flow (time frame: Through study completion, average 5 years). 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 NCT03854071, which also lists 24 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 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.