Marfan SyndromePhase 3NCT00782327
Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers
A Phase 3 study testing Losartan in people with Marfan Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2009to 26 Nov 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
- Patients > 10 years
- Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage
- Consent obtained (written) either for the patient and for his/her parents (<18y
- Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted)
- ARB naïve patients
Who cannot join
- Poor echocardiographic window,limiting the accurate measurement of the aortic root
- Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia
- Intolerance for ARB (eg angioedema)
- Pregnancy or breast feeding women
- Absence of effective contraception
- Liver function abnormalities
- Heart Failure
- Patients included in other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration.
Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg
- Conditions
- Marfan Syndrome
- Being tested
- Losartan, Placebo
- Medical subject headings
- Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg
PlaceboDrug
Daily placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Losartan Receives: Drug: Losartan |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary outcomes (11)
Comparative arterial stiffness
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Evaluation of progression of aortic regurgitation
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Aortic dissection incidence
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Aortic root surgery
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Progression of mitral regurgitation
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Left ventricular size and function
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Skeletal and somatic traits
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Quality of life
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Genetic polymorphisms affecting clinical symptoms and response to treatment
Measured: End of study
Death
Measured: At baseline and after 6 months, 1, 2 and 3 years follow-up
Aortic stiffness as assessed by MRI
Measured: At baseline and after 1 year and 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start1 Nov 2009
- Primary completion26 Nov 2014
- Study completion26 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marfan SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Sponsor
- Investigators
- Julie De Backer, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782327
- Sponsor's protocol ID
- 2008/503
- Status last verified
- Dec 2022
- First submitted
- 29 Oct 2008
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers
- ClinicalTrials.gov ID
- NCT00782327
- Acronym / sponsor ID
- 2008/503
- Conditions
- Marfan Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 26 Nov 2014 (actual)
- Study completion
- 26 Nov 2014 (actual)
- First posted
- 31 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.
To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration.
Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LosartanLosartan |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 10 years
- Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage
- Consent obtained (written) either for the patient and for his/her parents (<18y
- Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted)
- ARB naïve patients
Key exclusion criteria (8 listed)
- Poor echocardiographic window,limiting the accurate measurement of the aortic root
- Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia
- Intolerance for ARB (eg angioedema)
- Pregnancy or breast feeding women
- Absence of effective contraception
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 |
|---|---|---|
| LosartanDaily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg | Drug | 1 |
| PlaceboDaily placebo capsule | Drug | 2 |
Primary outcome
The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
11 secondary outcomes
Comparative arterial stiffness
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Evaluation of progression of aortic regurgitation
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Aortic dissection incidence
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Aortic root surgery
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Progression of mitral regurgitation
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Left ventricular size and function
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Skeletal and somatic traits
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Quality of life
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Genetic polymorphisms affecting clinical symptoms and response to treatment
Time frame: End of study
Death
Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up
Aortic stiffness as assessed by MRI
Time frame: At baseline and after 1 year and 3 years follow-up
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 22 Dec 2022.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Julie De Backer, MD, PhD principal investigator
University Hospital, Ghent
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 University Hospital, Ghent at 1 site in Belgium.
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 8 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 22 Dec 2022. 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 Belgium. 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 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?
The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score. (time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up). 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 22 Dec 2022.