Degenerative Aortic Valve StenosisNCT01993485
The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
An observational study of Degenerative Aortic Valve Stenosis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Aortic Valve Stenosis
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Mar 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with aortic valve stenosis screened for TAVI
Who may be able to join
- aortic valve stenosis
- screened for TAVI
- written informed consent
Who cannot join
- no written informed consent
- Patients with acute infections (CRP> 0.5 mg / dL)
- Patients with Atrial Fibrillation
- Patients with inflammatory and malignant diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Düsseldorf, 40225
About this study
Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects.
The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.
- Conditions
- Degenerative Aortic Valve Stenosis
- Keywords
- transaortic valve replacement (TAVI), endothelial function, circulating microparticles
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
endothelial function will be measured by flow mediated dilation (FMD)
Measured: Changes from Baseline in endothelial function at 3 months
plasma levels of circulating microparticles (MPs)
Measured: Changes from Baseline in Plasma Levels of MPs at 3 months
Secondary outcomes (3)
arterial stiffness
arterial stiffness will be measured by pulse wave analysis
Measured: Changes from Baseline in arterial stiffness at 3 months
blood pressure
Measured: Changes from Baseline in Hemodynamics at 3 months
heart rate
Measured: Changes from Baseline in Hemodynamics at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Ralf Westenfeld, MD, Principal investigator, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital DusseldorfMalte Kelm, Professor, Study chair, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993485
- Sponsor's protocol ID
- MP TAVI
- Status last verified
- Jun 2014
- First submitted
- 7 Nov 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
- ClinicalTrials.gov ID
- NCT01993485
- Acronym / sponsor ID
- MP TAVI
- Conditions
- Degenerative Aortic Valve Stenosis
- Keywords
- transaortic valve replacement (TAVI), endothelial function, circulating microparticles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Nov 2013 (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.
Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects.
The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with aortic valve stenosis screened for TAVI
Key inclusion criteria (3 listed)
- aortic valve stenosis
- screened for TAVI
- written informed consent
Key exclusion criteria (4 listed)
- no written informed consent
- Patients with acute infections (CRP> 0.5 mg / dL)
- Patients with Atrial Fibrillation
- Patients with inflammatory and malignant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
endothelial function
Time frame: Changes from Baseline in endothelial function at 3 months
endothelial function will be measured by flow mediated dilation (FMD)
plasma levels of circulating microparticles (MPs)
Time frame: Changes from Baseline in Plasma Levels of MPs at 3 months
3 secondary outcomes
arterial stiffness
Time frame: Changes from Baseline in arterial stiffness at 3 months
blood pressure
Time frame: Changes from Baseline in Hemodynamics at 3 months
heart rate
Time frame: Changes from Baseline in Hemodynamics at 3 months
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 4 Jun 2014.
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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.
Ralf Westenfeld, MD principal investigator
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Malte Kelm, Professor study chair
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Aortic Valve Stenosis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 3 inclusion and 4 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 4 Jun 2014. 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 Germany. 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?
endothelial function (time frame: Changes from Baseline in endothelial function at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2014.