New methods for assessing heart function in health and disease
Development of Novel Physiological CMR Methods in Health and Disease
NA · Sheffield Teaching Hospitals NHS Foundation Trust · NCT03854071
This study is testing new heart imaging techniques to see how well they can measure heart function in both healthy people and those with heart disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust (other) |
| Locations | 1 site (Sheffield, England) |
| Trial ID | NCT03854071 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate novel cardiovascular magnetic resonance (CMR) methods to assess heart function in both healthy individuals and patients with suspected or known heart disease. Participants will undergo physiological stress tests using advanced CMR imaging techniques, including four-dimensional flow CMR, to better understand cardiac function and flow dynamics. The study will involve five clinical subgroups, focusing on conditions such as heart failure and coronary artery disease, and will assess the impact of preload on cardiac performance. Follow-up scans will be conducted to evaluate the therapeutic implications of these new metrics.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers and patients aged 20 to 80 with suspected or known heart disease.
Not a fit: Patients with severe heart failure requiring IV therapy or significant valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for heart disease, enabling more effective treatment strategies.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cardiac assessment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sheffield, England
- Sheffield Teaching Hospitals NHS FT — Sheffield, England, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Helen Denney
- Email: H.Denney@nhs.net
- Phone: 0114 2269047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Pulmonary Hypertension, Myocardial Infarction, Coronary Artery Disease