Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.

A Phase 4 study testing Fluvastatin in people with Aortic Valve Stenosis, run by AORTICA Group at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Fluvastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 164 participants
Where: 1 siteSpain
Study dates: 1 Oct 2006to Jan 2018
Phase: Phase 4
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

Who may be able to join

Age ≥ 18 years
Asymptomatic
Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity >2 m/s)
Written informed consent to participate in the study
Patients capable to follow all conditions along the study.

Who cannot join

Symptomatic patients caused by aortic stenosis.
Patients on statins anytime in the year before inclusion.
Patients diagnosed of dyslipidemia requiring statins.
Temperature ³37,8 ºC in the week before inclusion.
Any cardiovascular event succeeding in the three months before inclusion
Known thyrotoxicosis

Show all 16Show fewer

Renal failure requiring hemodialysis
Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
Any surgery succeeding in the three months before inclusion.
Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
Patients with known muscular disease.
Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
Use of corticoids, immunosuppressors or non steroid drugs.
Any known sensitivity to study drug (fluvastatin) or class of study drug.
Patients participating in any study in the last year.
Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario de Salamanca
Salamanca, 37002

Other trials in Spain

About this study

Official title: Double Blind Randomized Phase IV Clinical Trial to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in the Haemodynamic Progression of Degenerative Aortic Stenosis. The AORTICA 1 Study.

Read the detailed description

This study will be a prospective, phase IV-III, randomized, double blinded, active controlled study, to evaluate the efficacy of fluvastatin on inflammatory markers in the haemodynamic progression of degenerative aortic stenosis. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease. Eligible patients with degenerative aortic stenosis will be randomized 1:1 to fluvastatin 80 mg once daily or placebo. The treatment should be continued until the study end (12 months). Follow up investigations will be performed after 3 months and at the end of the study (12 months).

Conditions: Aortic Valve Stenosis
Being tested: Fluvastatin
Keywords: C reactive protein, Inflammation, Aortic valve stenosis, progression
Medical subject headings: Aortic Valve Stenosis, Inflammation, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluvastatinDrug

Study groups in NCT00404287
Study group	Role	What they receive
fluvastatin	Active comparator	fluvastatin 80 mg Receives: Drug: Fluvastatin
placebo	Placebo comparator	Not described Receives: Drug: Fluvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
Measured: 12 months

Secondary outcomes (4)

To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)
Measured: 12 months
To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)
Measured: 12 months
To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)
Measured: 12 months
To study the safety and tolerability of fluvastatin in patients with aortic stenosis.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2006Jan 2018

First posted28 Nov 2006 (estimated)
Study start1 Oct 2006
Primary completion1 Nov 2014
Study completionJan 2018

Why it stopped: Funding not enough to complete the study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00404287
Sponsor's protocol ID: CXUO320BES04
Other IDs: EudraCT number 2005-003666-42
Status last verified: Jun 2019
First submitted: 27 Nov 2006
Last updated: 7 Jun 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Sanchez PL, Mazzone A. C-reactive protein in degenerative aortic valve stenosis. Cardiovasc Ultrasound. 2006 Jun 14;4:24. doi: 10.1186/1476-7120-4-24.
PubMed 16774687
Sanchez PL, Santos JL, Kaski JC, Cruz I, Arribas A, Villacorta E, Cascon M, Palacios IF, Martin-Luengo C; Grupo AORTICA (Grupo de Estudio de la Estenosis Aortica). Relation of circulating C-reactive protein to progression of aortic valve stenosis. Am J Cardiol. 2006 Jan 1;97(1):90-3. doi: 10.1016/j.amjcard.2005.07.113. Epub 2005 Nov 10.
PubMed 16377290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double Blind Randomized Phase IV Clinical Trial to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in the Haemodynamic Progression of Degenerative Aortic Stenosis. The AORTICA 1 Study.
ClinicalTrials.gov ID: NCT00404287
Acronym / sponsor ID: CXUO320BES04
Conditions: Aortic Valve Stenosis
Keywords: C reactive protein, Inflammation, Aortic valve stenosis, progression
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding not enough to complete the study
Enrolment: 164 participants (actual)
Lead sponsor: AORTICA GroupUniversity, hospital or other
Study start: 1 Oct 2006 (actual)
Primary completion: 1 Nov 2014 (actual)
Study completion: Jan 2018 (actual)
First posted: 28 Nov 2006 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
fluvastatin	Active comparator	Drug: Fluvastatinfluvastatin 80 mg
placebo	Placebo comparator	Drug: Fluvastatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 years
Asymptomatic
Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity >2 m/s)
Written informed consent to participate in the study
Patients capable to follow all conditions along the study.

Key exclusion criteria (16 listed)

Symptomatic patients caused by aortic stenosis.
Patients on statins anytime in the year before inclusion.
Patients diagnosed of dyslipidemia requiring statins.
Temperature ³37,8 ºC in the week before inclusion.
Any cardiovascular event succeeding in the three months before inclusion

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
Fluvastatin	Drug	fluvastatin, placebo

Primary outcome

To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
Time frame: 12 months

4 secondary outcomes

To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)
Time frame: 12 months
To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)
Time frame: 12 months
To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)
Time frame: 12 months
To study the safety and tolerability of fluvastatin in patients with aortic stenosis.
Time frame: 12 months

Results and safety

The study was stopped early (reason given: Funding not enough to complete the study). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
Background: PubMed 16774687Sanchez PL, Mazzone A. C-reactive protein in degenerative aortic valve stenosis. Cardiovasc Ultrasound. 2006 Jun 14;4:24. doi: 10.1186/1476-7120-4-24.
Background: PubMed 16377290Sanchez PL, Santos JL, Kaski JC, Cruz I, Arribas A, Villacorta E, Cascon M, Palacios IF, Martin-Luengo C; Grupo AORTICA (Grupo de Estudio de la Estenosis Aortica). Relation of circulating C-reactive protein to progression of aortic valve stenosis. Am J Cardiol. 2006 Jan 1;97(1):90-3. doi: 10.1016/j.amjcard.2005.07.113. Epub 2005 Nov 10.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

Pedro L Sanchez, MD, PhD principal investigator

Hospital Universitario Gregorio Marañón de Madrid

Candido Martin-Luengo, MD, PhD study chair

University of Salamanca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluvastatin in people with Aortic Valve Stenosis, run by AORTICA Group at 1 site in Spain.

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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 7 Jun 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding not enough to complete the study). Results are not available in the source record.

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?

To study changes in CRP (mg/dL) concentration at the end of the study (12 months) (time frame: 12 months). 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 NCT00404287, which also lists 2 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 7 Jun 2019.