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| Sponsor: | University of Bern |
|---|---|
| Collaborator: |
Swiss National Science Foundation |
| Information provided by: | University of Bern |
| ClinicalTrials.gov Identifier: | NCT00976625 |
Purpose
Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.
| Condition | Intervention |
|---|---|
|
Aortic Regurgitation |
Procedure: Aortic Valve Replacement |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation |
| Enrollment: | 26 |
| Study Start Date: | January 1996 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
Control group without intervention. Treatment group with aortic valve replacement.
|
|
| 2 |
Procedure: Aortic Valve Replacement
Surgical valve replacement of the aorta
|
Background
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.
Objective
Evaluation of myocardial structure and function in patients with chronic volume overload before and after valve replacement(LV-remodeling).
Methods
Pressure-volume measurements and myocardial biopsy samples for assessing myocardial function and structure.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations More Information
| Responsible Party: | Hospital ( University Hospital Bern ) |
| Study ID Numbers: | EK-32 16.9.1992 (Zürich) |
| Study First Received: | September 11, 2009 |
| Last Updated: | September 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00976625 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
diastolic function aortic regurgitation aortic valve replacement left ventricular hypertrophy |
myocardial structure LV remodeling Muscular regression LV fibrous tissue |
|
Heart Diseases Aortic Valve Insufficiency Cardiovascular Diseases Heart Valve Diseases |
