Marfan SyndromePhase 3LO-AT-MARFAN01NCT01145612
Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome
A Phase 3 study testing Losartan and Atenolol in people with Marfan Syndrome, run by Forteza, Albert, M.D. at 2 sites in Spain.
Trial summary
The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilatation in patients with Marfan syndrome. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Losartan and Atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2008to Feb 2013
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must conform to the diagnostic criteria Marfan syndrome according to the Ghent Criteria.
- Outpatient subjects.
- Male or female, aged between 5 and 60 years.
- Women who are in a childbearing age are required a result of negative Gonadotropin pregnancy test to be included in the study.
- Subjects must be able to take oral medication.
- After having received information about the study, subjects must understand the nature of it and give written informed consent.
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- For Subjects under 18 years, the informed consent must be signed by their parents or guardians.
- Subjects with a maximum diameter of the aorta, at length, <45 mm
- Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and three months after the last dose study medication.
- For the purposes of this study, women of childbearing potential is defined as: All female subjects after puberty unless they are post-menopausal for at least two years, or are surgically sterile. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device or use of the oral female contraceptive (or other hormonal methods).
Who cannot join
- Women who are pregnant, suspected to be pregnant or breast-feeding.
- Ongoing participation in another clinical trial or who received the investigational drug in the month prior to the inclusion in the study.
- Known or suspected failure to comply with the study protocol.
- Previous surgery: cardiac or at any segment of the aorta.
- Functional class III-IV.
- Maximum diameter of the aorta exceeding 45 mm
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- More than moderate valvular involvement.
- History or presence of respiratory failure, liver (ALT> 3 x ULN), renal (creatinine clearance <30 mL / min), gastrointestinal, hematological, endocrine, or any other situation that may affect the assessment of the study treatment, according to the investigator opinion.
- History of aortic dissection.
- History or presence of neurological disease (especially seizures, dementia ...).
- History or presence of alcohol abuse and / or toxic substances
- Uncontrolled depression.
- Any need for another antihypertensive treatment (betablockers, diuretics, calcium channel blockers, ACE inhibitors, ARBs, etc.)
- Hypersensitivity, intolerance or contraindication to any component of the study drug.
- Patients with a history of drug abuse or toxic dependence.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Vall d'Hebron
Barcelona, Barcelona, 08023
Hospital 12 de Octubre
Madrid, Madrid, 28045
About this study
Official title: A Clinical Trial to Assess the Efficacy and Safety of Losartan Versus Atenolol in the Prevention of Progressive Dilation of the Aorta in Patients With Marfan Syndrome.
The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilatation in patients with Marfan syndrome.
Read the detailed description
Marfan syndrome is a genetic disease of the connective tissue. Patients with Marfan syndrome experience an expansion of the aorta that can lead to dissection or rupture of it. This is the main cause of mortality in these patients.
The main objective of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
The measurement is made by echocardiography, assessing the diameter of the aorta in different zones: valve annulus, sinuses of Valsalva, sinotubular junction, ascending aorta, aortic arch, thoracic and abdominal aorta.
A total number of 150 subjects diagnosed with Marfan syndrome and who meet the diagnostic criteria of Ghent, of both sexes, 75 per treatment group, aged between 5 and 60, will be included in the study. The study is being conducted in two Spanish hospitals.
The treatment is maintained throughout the study period.
- Conditions
- Marfan Syndrome
- Being tested
- Losartan, Atenolol
- Keywords
- Aortic dilation, Marfan syndrome, Losartan, Atenolol
- 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
Losartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
AtenololDrug
Atenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Losartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg Receives: Drug: Losartan |
| Atenolol | Experimental | Atenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of aortic dilation in patients with Marfan syndrome.
Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
Measured: Until February 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startOct 2008
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forteza, Albert, M.D.
- Collaborators
- Ministry of Health, Spain
- Investigators
- Alberto Forteza, Dr, Principal investigatorArturo Evangelista, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145612
- Sponsor's protocol ID
- LO-AT-MARFAN-01
- Other IDs
- 2007-001125-97
- Acronym
- LO-AT-MARFAN01
- Status last verified
- Jun 2010
- First submitted
- 15 Jun 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Efficacy and Safety of Losartan Versus Atenolol in the Prevention of Progressive Dilation of the Aorta in Patients With Marfan Syndrome.
- ClinicalTrials.gov ID
- NCT01145612
- Acronym / sponsor ID
- LO-AT-MARFAN01 / LO-AT-MARFAN-01
- Conditions
- Marfan Syndrome
- Keywords
- Aortic dilation, Marfan syndrome, Losartan, Atenolol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Forteza, Albert, M.D.
- Collaborators
- Ministry of Health, Spain
- Study start
- Oct 2008
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 16 Jun 2010 (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 the efficacy of Losartan versus Atenolol in the progression of aortic dilatation in patients with Marfan syndrome.
Detailed description
Marfan syndrome is a genetic disease of the connective tissue. Patients with Marfan syndrome experience an expansion of the aorta that can lead to dissection or rupture of it. This is the main cause of mortality in these patients.
The main objective of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
The measurement is made by echocardiography, assessing the diameter of the aorta in different zones: valve annulus, sinuses of Valsalva, sinotubular junction, ascending aorta, aortic arch, thoracic and abdominal aorta.
A total number of 150 subjects diagnosed with Marfan syndrome and who meet the diagnostic criteria of Ghent, of both sexes, 75 per treatment group, aged between 5 and 60, will be included in the study. The study is being conducted in two Spanish hospitals.
The treatment is maintained throughout the study period.
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 |
|---|---|---|
| Losartan | Experimental | Drug: LosartanLosartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg |
| Atenolol | Experimental | Drug: AtenololAtenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Subjects must conform to the diagnostic criteria Marfan syndrome according to the Ghent Criteria.
- Outpatient subjects.
- Male or female, aged between 5 and 60 years.
- Women who are in a childbearing age are required a result of negative Gonadotropin pregnancy test to be included in the study.
- Subjects must be able to take oral medication.
Key exclusion criteria (15 listed)
- Women who are pregnant, suspected to be pregnant or breast-feeding.
- Ongoing participation in another clinical trial or who received the investigational drug in the month prior to the inclusion in the study.
- Known or suspected failure to comply with the study protocol.
- Previous surgery: cardiac or at any segment of the aorta.
- Functional class III-IV.
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 |
|---|---|---|
| LosartanLosartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg | Drug | Losartan |
| AtenololAtenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg | Drug | Atenolol |
Primary outcome
Progression of aortic dilation in patients with Marfan syndrome.
Time frame: Until February 2013
Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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.
Alberto Forteza, Dr principal investigator
Arturo Evangelista, Dr principal investigator
2 sites 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 and Atenolol in people with Marfan Syndrome, run by Forteza, Albert, M.D. at 2 sites 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 10 inclusion and 15 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 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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?
Progression of aortic dilation in patients with Marfan syndrome. (time frame: Until February 2013). 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 12 Aug 2010.