Aortic RegurgitationNCT00976625
Diastolic Dysfunction in Aortic Regurgitation
A study testing Aortic Valve Replacement in people with Aortic Regurgitation, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Regurgitation
- What is being tested?
- Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1996to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Severe aortic regurgitation
- Successful valve replacement
- Informed consent
- Sinus rhythm
- No comorbidities
- No bundle branch block
- No pregnancy
Who cannot join
- Unwillingness to undergo postop. cath
- diabetes mellitus
- arterial hypertension
- bleeding disorder
- pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation
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.
Read the 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.
- Conditions
- Aortic Regurgitation
- Being tested
- Aortic Valve Replacement
- Keywords
- diastolic function, aortic regurgitation, aortic valve replacement, left ventricular hypertrophy, myocardial structure, LV remodeling, Muscular regression, LV fibrous tissue
- Medical subject headings
- Aortic Valve Insufficiency, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Valve ReplacementProcedure or surgery
Surgical valve replacement of the aorta
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control group without intervention. Treatment group with aortic valve replacement. |
| 2 | Other | Not described Receives: Procedure: Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function and structure
Measured: 7-10 years
Secondary outcomes (1)
LV hypertrophy and passive elastic properties
Measured: 7-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJan 1996
- Primary completionDec 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Investigators
- Hess, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976625
- Sponsor's protocol ID
- EK-32 16.9.1992 (Zürich)
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 14 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19933939
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Diastolic Dysfunction Late After Valve Replacement in Severe Aortic Regurgitation
- ClinicalTrials.gov ID
- NCT00976625
- Acronym / sponsor ID
- EK-32 16.9.1992 (Zürich)
- Conditions
- Aortic Regurgitation
- Keywords
- diastolic function, aortic regurgitation, aortic valve replacement, left ventricular hypertrophy, myocardial structure, LV remodeling, Muscular regression, LV fibrous tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Jan 1996
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control group without intervention. Treatment group with aortic valve replacement. |
| 2 | Other | Procedure: Aortic Valve Replacement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Severe aortic regurgitation
- Successful valve replacement
- Informed consent
- Sinus rhythm
- No comorbidities
Key exclusion criteria (5 listed)
- Unwillingness to undergo postop. cath
- diabetes mellitus
- arterial hypertension
- bleeding disorder
- pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic Valve ReplacementSurgical valve replacement of the aorta | Procedure or surgery | 2 |
Primary outcome
Cardiac function and structure
Time frame: 7-10 years
1 secondary outcome
LV hypertrophy and passive elastic properties
Time frame: 7-10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2009.
- Derived from this study: PubMed 19933939Villari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hess principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic Valve Replacement in people with Aortic Regurgitation, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function and structure (time frame: 7-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2009.