Diastolic Dysfunction in Aortic Regurgitation

Aortic Regurgitation Clinical Trial

Official title:

Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976625
• Other study ID #: EK-32 16.9.1992 (Zürich)
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: September 11, 2009
• Start date: January 1996
• Est. completion date: December 2007

Study information

• Verified date: September 2009
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency

Intervention

Procedure:
• Aortic Valve Replacement
Surgical valve replacement of the aorta

Locations

Country	Name	City	State
Switzerland	Division of Cardiology	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function and structure		7-10 years	No
Secondary	LV hypertrophy and passive elastic properties		7-10 years	No