Diastolic Dysfunction in Aortic Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2007-12-31

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.

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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.

Conditions

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Aortic Regurgitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Control group without intervention. Treatment group with aortic valve replacement.

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Group Type OTHER

Aortic Valve Replacement

Intervention Type PROCEDURE

Surgical valve replacement of the aorta

Interventions

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Aortic Valve Replacement

Surgical valve replacement of the aorta

Intervention Type PROCEDURE

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