Diastolic Dysfunction in Aortic Regurgitation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation|
- Cardiac function and structure [ Time Frame: 7-10 years ] [ Designated as safety issue: No ]
- LV hypertrophy and passive elastic properties [ Time Frame: 7-10 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 1996|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
No Intervention: 1
Control group without intervention. Treatment group with aortic valve replacement.
Procedure: Aortic Valve Replacement
Surgical valve replacement of the aorta
Patients with severe aortic regurgitation show eccentric LV hypertrophy and structural changes of the myocardium. Reversibility of functional and structural changes after successful valve replacement may be limited. Persistent diastolic dysfunction has been observed in the present study late after aortic valve replacement. This finding has been explained by incomplete regression of the extra-cellular matrix 7 years after valve replacement. Interstitial fibrosis remains unchanged compared to the preoperative situation but was increased early after operation due to the reduction in LV muscle mass. Regression of LV hypertrophy was 40% after 2 and 55% after 7 years of valve replacement. Myocardial muscle fibers decreased slightly but remained hypertrophied even late after operation. Interstitital fibrosis was found to be positively correlated to myocardial stiffness and inversely to LV ejection fraction.
Thus, persistent diastolic dysfunction with maintained systolic ejection performance can be observed late after successful valve replacement in patients with severe aortic regurgitation. Altered diastolic function has been associated with increased filling pressures during strenuous exercise with signs of dyspnea.
Evaluation of myocardial structure and function in patients with chronic volume overload before and after valve replacement(LV-remodeling).
Pressure-volume measurements and myocardial biopsy samples for assessing myocardial function and structure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976625
|Division of Cardiology|
|Zürich, Switzerland, 8091|
|Principal Investigator:||Hess||University of Bern|