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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
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The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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
Patients will be selected in each group by the clinical specialist/research team as per the
published guidelines and local protocols
Other: Group 1
Heart failure patients with preserved ejection fraction
Other: Group 2
Heart failure patients with reserved ejection fraction
Other: Group 3
Patients with pulmonary hypertension
Other: Group 4
Patients with acute myocardial infarction
Other: Group 5
Patients with suspected but not treated coronary artery disease
Other: Group 6
Other: - intravenous fluid challenge
Patients will undergo a receive a pre-load increasing stress test with intravenous fluids depending on tolerability
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Sheffield Teaching Hospitals NHS FT
Sheffield, England, S10 2JF