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Diastolic Dysfunction in Aortic Regurgitation

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ClinicalTrials.gov Identifier: NCT00976625
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : September 14, 2009
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University of Bern

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.

Condition or disease Intervention/treatment Phase
Aortic Regurgitation Procedure: Aortic Valve Replacement Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation
Study Start Date : January 1996
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2007

Arm Intervention/treatment
No Intervention: 1
Control group without intervention. Treatment group with aortic valve replacement.
2 Procedure: Aortic Valve Replacement
Surgical valve replacement of the aorta



Primary Outcome Measures :
  1. Cardiac function and structure [ Time Frame: 7-10 years ]

Secondary Outcome Measures :
  1. LV hypertrophy and passive elastic properties [ Time Frame: 7-10 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976625


Locations
Switzerland
Division of Cardiology
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Bern
Swiss National Science Foundation
Investigators
Principal Investigator: Hess University of Bern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Bern, Hospital
ClinicalTrials.gov Identifier: NCT00976625     History of Changes
Other Study ID Numbers: EK-32 16.9.1992 (Zürich)
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: September 14, 2009
Last Verified: September 2009

Keywords provided by University of Bern:
diastolic function
aortic regurgitation
aortic valve replacement
left ventricular hypertrophy
myocardial structure
LV remodeling
Muscular regression
LV fibrous tissue

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases