Diastolic Dysfunction in Aortic Regurgitation
Primary Purpose
Aortic Regurgitation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aortic Valve Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Regurgitation focused on measuring diastolic function, aortic regurgitation, aortic valve replacement, left ventricular hypertrophy, myocardial structure, LV remodeling, Muscular regression, LV fibrous tissue
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
Sites / Locations
- Division of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
1
2
Arm Description
Control group without intervention. Treatment group with aortic valve replacement.
Outcomes
Primary Outcome Measures
Cardiac function and structure
Secondary Outcome Measures
LV hypertrophy and passive elastic properties
Full Information
NCT ID
NCT00976625
First Posted
September 11, 2009
Last Updated
September 11, 2009
Sponsor
University of Bern
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00976625
Brief Title
Diastolic Dysfunction in Aortic Regurgitation
Official Title
Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bern
Collaborators
Swiss National Science Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Regurgitation
Keywords
diastolic function, aortic regurgitation, aortic valve replacement, left ventricular hypertrophy, myocardial structure, LV remodeling, Muscular regression, LV fibrous tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Control group without intervention. Treatment group with aortic valve replacement.
Arm Title
2
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Aortic Valve Replacement
Intervention Description
Surgical valve replacement of the aorta
Primary Outcome Measure Information:
Title
Cardiac function and structure
Time Frame
7-10 years
Secondary Outcome Measure Information:
Title
LV hypertrophy and passive elastic properties
Time Frame
7-10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hess
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19933939
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.
Results Reference
derived
Learn more about this trial
Diastolic Dysfunction in Aortic Regurgitation
We'll reach out to this number within 24 hrs