Diastolic Dysfunction in Aortic Regurgitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation

Conditions
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Aortic Regurgitation

Intervention / Treatment
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* Procedure: Aortic Valve Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe aortic regurgitation Successful valve replacement Informed consent Sinus rhythm No comorbidities No bundle branch block No pregnancy Exclusion Criteria Unwillingness to undergo postop. cath diabetes mellitus arterial hypertension bleeding disorder pulmonary hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Control group without intervention. Treatment group with aortic valve replacement. | |
| Other: 2<br> | Procedure: Aortic Valve Replacement<br>* Surgical valve replacement of the aorta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function and structure |  | 7-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV hypertrophy and passive elastic properties |  | 7-10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diastolic function, aortic regurgitation, aortic valve replacement, left ventricular hypertrophy, myocardial structure, LV remodeling, Muscular regression, LV fibrous tissue