Development of Novel Physiological CMR Methods in Health and Disease

NCT03854071 | Recruiting

• 1 other identifier: STH20184
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Pulmonary Hypertension; Myocardial Infarction; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, average 5 years

Secondary Outcomes (2)

• Secondary 4D CMR Flow

  Through study completion, average 5 years

• Volumetric and functional parameters

  Through study completion, average 5 years

Study Arms (6)

Group 1

OTHER

Heart failure patients with preserved ejection fraction

Other: intravenous fluid challenge

Group 2

OTHER

Heart failure patients with reserved ejection fraction

Other: intravenous fluid challenge

Group 3

OTHER

Patients with pulmonary hypertension

Other: intravenous fluid challenge

Group 4

OTHER

Patients with acute myocardial infarction

Other: intravenous fluid challenge

Group 5

OTHER

Patients with suspected but not treated coronary artery disease

Other: intravenous fluid challenge

Group 6

OTHER

Healthy Volunteers

Other: intravenous fluid challenge

Interventions

intravenous fluid challenge OTHER

Patients will undergo a receive a pre-load increasing stress test with intravenous fluids depending on tolerability

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, England, S10 2JF, United Kingdom

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary; Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Myocardial Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Helen Denney

CONTACT

0114 2269047; H.Denney@nhs.net

Amber Ford

CONTACT

0114 2269047; amber.ford3@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 26, 2019
• Study Start: July 30, 2018
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

GB (1)