Diastolic Function Assessment With Cardiac Magnetic Resonance Imaging

NCT05438030 | Unknown

• 1 other identifier: 21HH7048
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac magnetic resonance (CMR) imaging is excellent at assessing the contractility of the heart muscle. However, relatively little is known about CMR's ability to assess the relaxation (diastolic function) of the heart between heart beats, where echocardiography remains the gold standard. This is important because in 30% of heart failure patients the overwhelming problem is diastolic dysfunction, and so they often need both tests. The investigators wish to investigate how to best make measurements using CMR to identify those with impaired diastolic function, in the context of the current gold standard test (echocardiography).

Conditions

Diastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy using e:E'

  The accuracy rate using the ratio (dimensionless) of early mitral valve inflow (centimetres per second) to the mitral valve peak relaxation velocity (centimeters per second), measured using echocardiography and cardiac MRI.

  15 weeks

Study Arms (1)

Paired cardiac MRI and echocardiographic measurements

EXPERIMENTAL

Diagnostic Test: Cardiac MRI scan; Diagnostic Test: Echocardiogram scan

Interventions

Cardiac MRI scan DIAGNOSTIC_TEST

Undertaken at the radiology department at Hammersmith Hospital. The scan will be performed by the MRI radiographers, under the supervision of a consultant radiologist or cardiologist.

Paired cardiac MRI and echocardiographic measurements

Echocardiogram scan DIAGNOSTIC_TEST

Undertaken at the Peart Rose research unit, by a British Society of Echocardiography accredited sonographer.

Paired cardiac MRI and echocardiographic measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1: patients with preserved systolic function, grade 2 or more diastolic dysfunction on echocardiography, a raised BNP, and a diagnosis typically causing HFPEF (e.g., hypertrophic cardiomyopathy, severe aortic stenosis, or cardiac amyloidosis).
• Cohort 2: patients without grade 2 or more diastolic dysfunction on echocardiography.

You may not qualify if:

• Contraindications to CMR or echocardiographic scanning - for safety.
• Contraindications to gadolinium contrast agents - for safety.
• Severe claustrophobia - extra CMR scanning may prove too difficult.
• Pregnancy - likely to be undergoing progressive physiological changes in the conduct of the study which may invalid assumptions about repeat scanning.
• The ability to provide informed consent.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

Central Study Contacts

Becky Ward

CONTACT

0207 594 9459; becky.ward@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 29, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

GB (1)