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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
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 11, 2009
Last Updated
September 11, 2009
Sponsor
University of Bern
Collaborators
Swiss National Science Foundation
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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
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Diastolic Dysfunction in Aortic Regurgitation

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