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Diastolic Dysfunction in Aortic Regurgitation

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00976625
First received: September 11, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Aortic Regurgitation
 Procedure: Aortic Valve Replacement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Cardiac function and structure [ Time Frame: 7-10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LV hypertrophy and passive elastic properties [ Time Frame: 7-10 years ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 1996
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control group without intervention. Treatment group with aortic valve replacement.
2 Procedure: Aortic Valve Replacement
Surgical valve replacement of the aorta

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Bern

Additional 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)
Study First Received: September 11, 2009
Last Updated: September 11, 2009
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 16, 2013