AtherosclerosisNCT00114491
Rosuvastatin Affecting Aortic Valve Endothelium
An observational study of Atherosclerosis and Hypercholesterolemia, run by Hospital Pedro Hispano at 1 site in Portugal.
Trial summary
Recent studies support the hypothesis that aortic stenosis (AS) develops due to atherosclerosis affecting the aortic valve endothelium. The study's aim was to assess Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating low-density lipoprotein (LDL) in patients with AS according to the… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Hypercholesterolemia
- What is being tested?
- Rosuvastatin
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2003to May 2005
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic AS
- Normal ejection fraction
- Elevated LDL >130 mg/dl
Who cannot join
- Echocardiographic evidence of rheumatic mitral valve disease,
- Previous statin therapy,
- Congenital heart disease (bicuspid aortic valve),
- Subaortic obstruction,
- Creatinine ≥ 2,0 mg/dl (to avoid the potential confounder of an elevated serum [CaP04]),
- Evidence of liver disease,
- Greater than mild aortic regurgitation and previous aortic valve surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE
Recent studies support the hypothesis that aortic stenosis (AS) develops due to atherosclerosis affecting the aortic valve endothelium. The study's aim was to assess Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating low-density lipoprotein (LDL) in patients with AS according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII) guidelines for one year.
Read the detailed description
Background: Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. The aim of this study was to assess the effect of Rosuvastatin on hemodynamic progression of aortic stenosis by treating patients with aortic stenosis and elevated LDL-cholesterol for 18 months.
Methods: We performed an open-label, prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis (AVA≥ 1.0 cm2), (mean age 73.7±8.9 years; 57 men and 64 women), treated with and without Rosuvastatin according to the NCEP-ATPIII guidelines. Echocardiographic, serum lipid, and inflammatory markers were measured at baseline and every 6 months for 18 months.
- Conditions
- Atherosclerosis, Hypercholesterolemia
- Being tested
- Rosuvastatin
- Keywords
- Aortic Stenosis, Statins, Hypercholesterolemia
- Medical subject headings
- Atherosclerosis, Hypercholesterolemia, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2005 (estimated)
- Study startSep 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Hospital Pedro Hispano
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Investigators
- Luis M Moura, Principal investigator, Hospital Pedro Hispano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114491
- Sponsor's protocol ID
- 22352
- Status last verified
- Oct 2006
- First submitted
- 15 Jun 2005
- Last updated
- 31 Oct 2006
- Results posted
- No
Publications
Rajamannan NM, Subramaniam M, Stock SR, Stone NJ, Springett M, Ignatiev KI, McConnell JP, Singh RJ, Bonow RO, Spelsberg TC. Atorvastatin inhibits calcification and enhances nitric oxide synthase production in the hypercholesterolaemic aortic valve. Heart. 2005 Jun;91(6):806-10. doi: 10.1136/hrt.2003.029785.
PubMed 15894785Makkena B, Salti H, Subramaniam M, Thennapan S, Bonow RH, Caira F, Bonow RO, Spelsberg TC, Rajamannan NM. Atorvastatin decreases cellular proliferation and bone matrix expression in the hypercholesterolemic mitral valve. J Am Coll Cardiol. 2005 Feb 15;45(4):631-3. doi: 10.1016/j.jacc.2004.11.023. No abstract available.
PubMed 15708716Rajamannan NM. Is it time for medical therapy for aortic valve disease? Expert Rev Cardiovasc Ther. 2004 Nov;2(6):845-54. doi: 10.1586/14779072.2.6.845.
PubMed 15500430Rajamannan NM, Edwards WD, Spelsberg TC. Hypercholesterolemic aortic-valve disease. N Engl J Med. 2003 Aug 14;349(7):717-8. doi: 10.1056/NEJMc031360. No abstract available.
PubMed 12917318Otto CM. Why is aortic sclerosis associated with adverse clinical outcomes? J Am Coll Cardiol. 2004 Jan 21;43(2):176-8. doi: 10.1016/j.jacc.2003.10.027. No abstract available.
PubMed 14736433Rajamannan NM, Otto CM. Targeted therapy to prevent progression of calcific aortic stenosis. Circulation. 2004 Sep 7;110(10):1180-2. doi: 10.1161/01.CIR.0000140722.85490.EA. No abstract available.
PubMed 15353511Rajamannan NM, Subramaniam M, Rickard D, Stock SR, Donovan J, Springett M, Orszulak T, Fullerton DA, Tajik AJ, Bonow RO, Spelsberg T. Human aortic valve calcification is associated with an osteoblast phenotype. Circulation. 2003 May 6;107(17):2181-4. doi: 10.1161/01.CIR.0000070591.21548.69. Epub 2003 Apr 28.
PubMed 12719282Moura LM, Ramos SF, Zamorano JL, Barros IM, Azevedo LF, Rocha-Goncalves F, Rajamannan NM. Rosuvastatin affecting aortic valve endothelium to slow the progression of aortic stenosis. J Am Coll Cardiol. 2007 Feb 6;49(5):554-61. doi: 10.1016/j.jacc.2006.07.072. Epub 2007 Jan 22.
PubMed 17276178
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE
- ClinicalTrials.gov ID
- NCT00114491
- Acronym / sponsor ID
- 22352
- Conditions
- Atherosclerosis, Hypercholesterolemia
- Keywords
- Aortic Stenosis, Statins, Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Hospital Pedro HispanoUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Sep 2003
- Study completion
- May 2005
- First posted
- 16 Jun 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.
Recent studies support the hypothesis that aortic stenosis (AS) develops due to atherosclerosis affecting the aortic valve endothelium. The study's aim was to assess Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating low-density lipoprotein (LDL) in patients with AS according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII) guidelines for one year.
Detailed description
Background: Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. The aim of this study was to assess the effect of Rosuvastatin on hemodynamic progression of aortic stenosis by treating patients with aortic stenosis and elevated LDL-cholesterol for 18 months.
Methods: We performed an open-label, prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis (AVA≥ 1.0 cm2), (mean age 73.7±8.9 years; 57 men and 64 women), treated with and without Rosuvastatin according to the NCEP-ATPIII guidelines. Echocardiographic, serum lipid, and inflammatory markers were measured at baseline and every 6 months for 18 months.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asymptomatic AS
- Normal ejection fraction
- Elevated LDL >130 mg/dl
Key exclusion criteria (7 listed)
- Echocardiographic evidence of rheumatic mitral valve disease,
- Previous statin therapy,
- Congenital heart disease (bicuspid aortic valve),
- Subaortic obstruction,
- Creatinine ≥ 2,0 mg/dl (to avoid the potential confounder of an elevated serum [CaP04]),
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 |
|---|---|---|
| Rosuvastatin | Drug | – |
Primary outcome
Not reported in the source record.
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 31 Oct 2006.
- Results publication: PubMed 15894785Rajamannan NM, Subramaniam M, Stock SR, Stone NJ, Springett M, Ignatiev KI, McConnell JP, Singh RJ, Bonow RO, Spelsberg TC. Atorvastatin inhibits calcification and enhances nitric oxide synthase production in the hypercholesterolaemic aortic valve. Heart. 2005 Jun;91(6):806-10. doi: 10.1136/hrt.2003.029785.
- Results publication: PubMed 15708716Makkena B, Salti H, Subramaniam M, Thennapan S, Bonow RH, Caira F, Bonow RO, Spelsberg TC, Rajamannan NM. Atorvastatin decreases cellular proliferation and bone matrix expression in the hypercholesterolemic mitral valve. J Am Coll Cardiol. 2005 Feb 15;45(4):631-3. doi: 10.1016/j.jacc.2004.11.023. No abstract available.
- Results publication: PubMed 15500430Rajamannan NM. Is it time for medical therapy for aortic valve disease? Expert Rev Cardiovasc Ther. 2004 Nov;2(6):845-54. doi: 10.1586/14779072.2.6.845.
- Results publication: PubMed 12917318Rajamannan NM, Edwards WD, Spelsberg TC. Hypercholesterolemic aortic-valve disease. N Engl J Med. 2003 Aug 14;349(7):717-8. doi: 10.1056/NEJMc031360. No abstract available.
- Results publication: PubMed 14736433Otto CM. Why is aortic sclerosis associated with adverse clinical outcomes? J Am Coll Cardiol. 2004 Jan 21;43(2):176-8. doi: 10.1016/j.jacc.2003.10.027. No abstract available.
- Results publication: PubMed 15353511Rajamannan NM, Otto CM. Targeted therapy to prevent progression of calcific aortic stenosis. Circulation. 2004 Sep 7;110(10):1180-2. doi: 10.1161/01.CIR.0000140722.85490.EA. No abstract available.
- Results publication: PubMed 12719282Rajamannan NM, Subramaniam M, Rickard D, Stock SR, Donovan J, Springett M, Orszulak T, Fullerton DA, Tajik AJ, Bonow RO, Spelsberg T. Human aortic valve calcification is associated with an osteoblast phenotype. Circulation. 2003 May 6;107(17):2181-4. doi: 10.1161/01.CIR.0000070591.21548.69. Epub 2003 Apr 28.
- Derived from this study: PubMed 17276178Moura LM, Ramos SF, Zamorano JL, Barros IM, Azevedo LF, Rocha-Goncalves F, Rajamannan NM. Rosuvastatin affecting aortic valve endothelium to slow the progression of aortic stenosis. J Am Coll Cardiol. 2007 Feb 6;49(5):554-61. doi: 10.1016/j.jacc.2006.07.072. Epub 2007 Jan 22.
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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.
Luis M Moura principal investigator
Hospital Pedro Hispano
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 Atherosclerosis and Hypercholesterolemia, run by Hospital Pedro Hispano at 1 site in Portugal.
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 7 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 31 Oct 2006. 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 Portugal. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114491, which also lists 8 linked publications.
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 31 Oct 2006.