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NCT03854071Recruiting

Development of Novel Physiological CMR Methods in Health and Disease

Source: ClinicalTrials.gov · Last updated 18 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
135 (estimated)
First submitted
19 Feb 2019
Start date
30 Jul 2018
Primary completion date
1 Jan 2030
Lead sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
NCT number
NCT03854071

What you commit to

  • Study type: Interventional
  • Planned participants: 135
  • From 30 Jul 2018 to the primary completion date, 1 Jan 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to MRI (as per standard MRI screening questionnaire issued to patients prior to clinical MRI procedures)

Other illness

  • 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

Other

  • Patient with in atrial fibrillation will be excluded

Who the study is looking for

  • 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

Age in the registry: 20 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sheffield Teaching Hospitals NHS FT
Coordinator of this site? Confirm its status
SheffieldUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.