Marfan SyndromePhase 3MARFANSARTANNCT00763893
Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
A Phase 3 study testing Losartan in people with Marfan Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Dec 2014
- Phase
- Phase 3
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 10 years or older
- Marfan syndrome according to international criteria Signed informed consent
Who cannot join
- Previous surgery of the ascending aorta, or surgery planned
- Non echogenicity
- Contre-indication lactose
- Pregnancy on going or planned within 3 years
- Breast feeding
- Participation in another clinical study
- Non member of the social security or CMU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.
Read the detailed description
Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy
Inclusion criteria :
10 years or older Marfan syndrome according to international criteria Signed informed consent
Non inclusion :
Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU
Number of subjects : the number of subjects (150 per group) is derived from the study from Shores et al (1994) demonstrating the benefit of beta-blockade in Marfan patient and uses a decrease by half of the aortic dilatation with losartan
Follow-up is 3 years, after inclusion period of 2 years. A total of 5 years is expected
Methods : randomised double blind vs placebo study. All French centres de competence for marfan syndrome and the centre de reference are participating in the study.
End points : main endpoint is evolution of normalised aortic diameter. Secondary endpoints include clinical events (cardiac surgery or aortic dissection, hospitalisation in cardiology department, death), tolerance of the drug, and quality of life.
- Conditions
- Marfan Syndrome
- Being tested
- placebo, Losartan
- Keywords
- Marfan syndrome, Angiotensin II Type 1 Receptor Blockers, Aortic Aneurysm, Thoracic
- Medical subject headings
- Marfan Syndrome, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration.
LosartanDrug
50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg
| Study group | Role | What they receive |
|---|---|---|
| A: Placebo | Placebo comparator | placebo Receives: Drug: placebo |
| B: Losartan | Active comparator | Losartan Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
normalised aortic diameter at the level of the sinus of valsalva
Measured: every six months
Secondary outcomes (1)
cardiac surgery, hospitalisation in cardiology ward, death
Measured: during the follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2014
- Study completionDec 2014
Why it stopped: A similar publication has been released, suggesting a beneficial effect of sartans, and only 15 patients remained to be seen for their visit at 36 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume JONDEAU, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763893
- Sponsor's protocol ID
- P060210
- Other IDs
- 2006-006112-30
- Acronym
- MARFANSARTAN
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2008
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Detaint D, Aegerter P, Tubach F, Hoffman I, Plauchu H, Dulac Y, Faivre LO, Delrue MA, Collignon P, Odent S, Tchitchinadze M, Bouffard C, Arnoult F, Gautier M, Boileau C, Jondeau G. Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. Arch Cardiovasc Dis. 2010 May;103(5):317-25. doi: 10.1016/j.acvd.2010.04.008. Epub 2010 Jul 1.
PubMed 20619242Milleron O, Arnoult F, Ropers J, Aegerter P, Detaint D, Delorme G, Attias D, Tubach F, Dupuis-Girod S, Plauchu H, Barthelet M, Sassolas F, Pangaud N, Naudion S, Thomas-Chabaneix J, Dulac Y, Edouard T, Wolf JE, Faivre L, Odent S, Basquin A, Habib G, Collignon P, Boileau C, Jondeau G. Marfan Sartan: a randomized, double-blind, placebo-controlled trial. Eur Heart J. 2015 Aug 21;36(32):2160-6. doi: 10.1093/eurheartj/ehv151. Epub 2015 May 2.
PubMed 25935877Jiang P, Loyau S, Tchitchinadze M, Ropers J, Jondeau G, Jandrot-Perrus M. Inhibition of Glycoprotein VI Clustering by Collagen as a Mechanism of Inhibiting Collagen-Induced Platelet Responses: The Example of Losartan. PLoS One. 2015 Jun 8;10(6):e0128744. doi: 10.1371/journal.pone.0128744. eCollection 2015.
PubMed 26052700
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
- ClinicalTrials.gov ID
- NCT00763893
- Acronym / sponsor ID
- MARFANSARTAN / P060210
- Conditions
- Marfan Syndrome
- Keywords
- Marfan syndrome, Angiotensin II Type 1 Receptor Blockers, Aortic Aneurysm, Thoracic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A similar publication has been released, suggesting a beneficial effect of sartans, and only 15 patients remained to be seen for their visit at 36 months.
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Oct 2008 (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.
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.
Detailed description
Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy
Inclusion criteria :
10 years or older Marfan syndrome according to international criteria Signed informed consent
Non inclusion :
Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU
Number of subjects : the number of subjects (150 per group) is derived from the study from Shores et al (1994) demonstrating the benefit of beta-blockade in Marfan patient and uses a decrease by half of the aortic dilatation with losartan
Follow-up is 3 years, after inclusion period of 2 years. A total of 5 years is expected
Methods : randomised double blind vs placebo study. All French centres de competence for marfan syndrome and the centre de reference are participating in the study.
End points : main endpoint is evolution of normalised aortic diameter. Secondary endpoints include clinical events (cardiac surgery or aortic dissection, hospitalisation in cardiology department, death), tolerance of the drug, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Placebo | Placebo comparator | Drug: placeboplacebo |
| B: Losartan | Active comparator | Drug: LosartanLosartan |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 10 years or older
- Marfan syndrome according to international criteria Signed informed consent
Key exclusion criteria (7 listed)
- Previous surgery of the ascending aorta, or surgery planned
- Non echogenicity
- Contre-indication lactose
- Pregnancy on going or planned within 3 years
- Breast feeding
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 |
|---|---|---|
| placeboCover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration. | Drug | A: Placebo |
| Losartan50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg | Drug | B: Losartan |
Primary outcome
normalised aortic diameter at the level of the sinus of valsalva
Time frame: every six months
1 secondary outcome
cardiac surgery, hospitalisation in cardiology ward, death
Time frame: during the follow up
Results and safety
The study was stopped early (reason given: A similar publication has been released, suggesting a beneficial effect of sartans, and only 15 patients remained to be seen for their visit at 36 months.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Results publication: PubMed 20619242Detaint D, Aegerter P, Tubach F, Hoffman I, Plauchu H, Dulac Y, Faivre LO, Delrue MA, Collignon P, Odent S, Tchitchinadze M, Bouffard C, Arnoult F, Gautier M, Boileau C, Jondeau G. Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. Arch Cardiovasc Dis. 2010 May;103(5):317-25. doi: 10.1016/j.acvd.2010.04.008. Epub 2010 Jul 1.
- Results publication: PubMed 25935877Milleron O, Arnoult F, Ropers J, Aegerter P, Detaint D, Delorme G, Attias D, Tubach F, Dupuis-Girod S, Plauchu H, Barthelet M, Sassolas F, Pangaud N, Naudion S, Thomas-Chabaneix J, Dulac Y, Edouard T, Wolf JE, Faivre L, Odent S, Basquin A, Habib G, Collignon P, Boileau C, Jondeau G. Marfan Sartan: a randomized, double-blind, placebo-controlled trial. Eur Heart J. 2015 Aug 21;36(32):2160-6. doi: 10.1093/eurheartj/ehv151. Epub 2015 May 2.
- Derived from this study: PubMed 26052700Jiang P, Loyau S, Tchitchinadze M, Ropers J, Jondeau G, Jandrot-Perrus M. Inhibition of Glycoprotein VI Clustering by Collagen as a Mechanism of Inhibiting Collagen-Induced Platelet Responses: The Example of Losartan. PLoS One. 2015 Jun 8;10(6):e0128744. doi: 10.1371/journal.pone.0128744. eCollection 2015.
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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.
Guillaume JONDEAU, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan in people with Marfan Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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: stopped early, as of the sponsor's last update on 4 Nov 2015. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: A similar publication has been released, suggesting a beneficial effect of sartans, and only 15 patients remained to be seen for their visit at 36 months.). 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?
normalised aortic diameter at the level of the sinus of valsalva (time frame: every six 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 NCT00763893, which also lists 3 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 4 Nov 2015.