NCT01638156

Cardiac MRI for Severe Aortic Stenosis

Arterial Stiffness and Wave Reflections as Determinants of Regression of Left Ventricular Hypertrophy and Fibrosis Assessed With Cardiac MRI After Aortic Valve Replacement for Severe Aortic Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: American College of Radiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the importance of arterial stiffness and wave reflections as determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using cardiac magnetic resonance imaging \[MRI\]) after correction of severe stenosis of the aortic valve. The hypothesis will test whether stiff arteries and increased wave reflections impede pumping of blood by the LV after aortic valve replacement (AVR)and precent adequate regression (improvement) of hypertrophy and fibrosis of the myocardium despite correction of aortic valve stenosis.

Detailed description

A total of 80 participants will be enrolled into the study from site with the protocol-required technology. The Pennsylvania Department of Health funding for this trial is limited to sites in Pennsylvania. Participants will undergo pre- and post-operative cardiac MRI, blood draws, a 6-minute walk test, arterial tonometry, medical history assessment, and quality-of-life questionnaires to characterize the pathophysiologic factors causing variability in regression after AVR. Researchers will evaluate the role of specific hemodynamic abnormalities as determinants of post-AVR LV remodeling (LV hypertrophy and LV myocardial fibrosis) as seen on contrast-enhanced cardiac MRI. The trial also will evaluate a non-contrast-enhanced MRI approach (T1rho) potentially effective in assessing LV myocardial fibrosis.

Conditions

• Aortic Stenosis

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-31
• Completion: 2015-12-31
• First posted: 2012-07-11
• Last updated: 2023-08-01

Locations

2 sites across 1 country: United States