Clinical trial NCT00976625: Diastolic Dysfunction in Aortic Regurgitation
Official title: Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Regurgitation
Keywords: diastolic function
aortic regurgitation
aortic valve replacement
left ventricular hypertrophy
myocardial structure
LV remodeling
Muscular regression
LV fibrous tissue
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2009-09-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac function and structure
timeFrame: 7-10 years
Secondary outcomes:
measure: LV hypertrophy and passive elastic properties
timeFrame: 7-10 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Division of Cardiology
Study officials:
affiliation: University of Bern
name: Hess
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villari B, Sossalla S, Ciampi Q, Petruzziello B, Turina J, Schneider J, Turina M, Hess OM. Persistent diastolic dysfunction late after valve replacement in severe aortic regurgitation. Circulation. 2009 Dec 8;120(23):2386-92. doi: 10.1161/CIRCULATIONAHA.108.812685. Epub 2009 Nov 23.