NCT03854071 Development of Novel Physiological CMR Methods in Health and Disease
| NCT ID | NCT03854071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2018-07-30 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2018-07-30 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03854071 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03854071 currently recruiting?
Yes, NCT03854071 is actively recruiting participants. Contact the research team at H.Denney@nhs.net for enrollment information.
Where is the NCT03854071 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT03854071 clinical trial?
NCT03854071 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 135 participants.
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