Aortic Valve StenosisPhase 2NCT00176410
Statin Therapy in Asymptomatic Aortic Stenosis
A Phase 2 study testing fluvastatin in people with Aortic Valve Stenosis, run by University of Leipzig at 1 site in Germany.
Trial summary
There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- fluvastatin
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Dec 2009
- Phase
- Phase 2
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Mild to moderate aortic stenosis
- No symptoms caused by aortic stenosis
- Written informed consent to participate in the study
- Aortic valve leaflet thickening with reduced systolic opening
- Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2
- Maximum aortic jet velocity at rest > 2,5 m/s
Who cannot join
- Symptoms caused by aortic stenosis
- Aortic valve area < 0,7 cm2
- Severe aortic regurgitation
- Reduced left ventricular ejection fraction (< 50%)
- Any valve disease with indication for surgery
- Coronary artery disease
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- Therapy refractory arterial hypertension
- Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible
- Other indication for treatment with statins
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- Use of any other investigational agent in the last 30 days
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig - Heart Center
Leipzig, Saxony, 04289
Claudia Walther, MD, xx49-341-8651428, waltherc@medizin.uni-leipzig.de
Claudia A Walther, MD
About this study
There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.
Read the detailed description
This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.
- Conditions
- Aortic Valve Stenosis
- Being tested
- fluvastatin
- Keywords
- aortic valve stenosis, statin therapy
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluvastatinDrug
40mg fluvastatin daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of calcified aortic stenosis measured by:
Measured: 24 months
Transthoracic echocardiography (P max/ mean; V max; AVA)
Measured: 24 months
Catheterization (peak to peak gradient, LV-function, compliance)
Measured: 24 months
Secondary outcomes (1)
Number of cardiovascular events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Gerhard Schuler, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176410
- Sponsor's protocol ID
- Leipzig aortic valve study
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Therapy in Asymptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT00176410
- Acronym / sponsor ID
- Leipzig aortic valve study
- Conditions
- Aortic Valve Stenosis
- Keywords
- aortic valve stenosis, statin therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2003
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 15 Sep 2005 (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.
There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.
Detailed description
This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 21 years
- Mild to moderate aortic stenosis
- No symptoms caused by aortic stenosis
- Written informed consent to participate in the study
- Aortic valve leaflet thickening with reduced systolic opening
Key exclusion criteria (13 listed)
- Symptoms caused by aortic stenosis
- Aortic valve area < 0,7 cm2
- Severe aortic regurgitation
- Reduced left ventricular ejection fraction (< 50%)
- Any valve disease with indication for surgery
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 |
|---|---|---|
| fluvastatin40mg fluvastatin daily | Drug | – |
Primary outcome
Progression of calcified aortic stenosis measured by:
Time frame: 24 months
Transthoracic echocardiography (P max/ mean; V max; AVA)
Time frame: 24 months
Catheterization (peak to peak gradient, LV-function, compliance)
Time frame: 24 months
1 secondary outcome
Number of cardiovascular events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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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.
Gerhard Schuler, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluvastatin in people with Aortic Valve Stenosis, run by University of Leipzig 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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Jan 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Walther, MD (xx49-341-8651428, waltherc@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of calcified aortic stenosis measured by: (time frame: 24 months). The study lists 3 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 14 Jan 2010.