Marfan SyndromePhase 2MFSNCT00651235
A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
A Phase 2 study testing Losartan and Atenolol or Propranolol and Atenolol or Propranolol in people with Marfan Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Losartan and Atenolol or Propranolol and Atenolol or Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2007to Jun 2011
- Phase
- Phase 2
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Marfan syndrome with recognized aortic root dilation
- Patients must be older than one year of age
- Beta-blocker treatment at least three months
- Must sign an informed consent form
Who cannot join
- Prior to aortic root surgery
- Aortic root dimension more than 5.5cm
- Aortic surgery within 6 months
- Diabetes mellitus or liver and renal dysfunction or asthma
- Pregnancy
- Intolerance to Losartan therapy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Randomized, Open-label, Active Control Trial to Evaluate the Effect of LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.
Read the detailed description
Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal system. The most life-threatening complication of MFS is progressive aortic root dilation leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1) antagonist, is a drug already in clinical use for hypertension and type II diabetic nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation prevention.
- Conditions
- Marfan Syndrome
- Being tested
- Losartan and Atenolol or Propranolol, Atenolol or Propranolol
- Medical subject headings
- Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan and Atenolol or PropranololDrug
Also called Cozaar and Tenormin or Inderal
50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children.
Losartan is 100 mg/day for adult and 50 mg/day for children.
Atenolol or PropranololDrug
Also called Tenormin or Inderal
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | In combination therapy,the maximal dose of Losartan is 100 mg/day for adult and 50 mg/day for children. 50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children Receives: Drug: Losartan and Atenolol or Propranolol |
| A | Active comparator | The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children. Receives: Drug: Atenolol or Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiograms
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 National Taiwan University HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Hwan Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651235
- Sponsor's protocol ID
- 200610030M
- Acronym
- MFS
- Status last verified
- Jun 2010
- First submitted
- 3 Mar 2008
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiu HH, Wu MH, Wang JK, Lu CW, Chiu SN, Chen CA, Lin MT, Hu FC. Losartan added to beta-blockade therapy for aortic root dilation in Marfan syndrome: a randomized, open-label pilot study. Mayo Clin Proc. 2013 Mar;88(3):271-6. doi: 10.1016/j.mayocp.2012.11.005. Epub 2013 Jan 12.
PubMed 23321647
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active Control Trial to Evaluate the Effect of LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
- ClinicalTrials.gov ID
- NCT00651235
- Acronym / sponsor ID
- MFS / 200610030M
- Conditions
- Marfan Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 2 Apr 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 assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.
Detailed description
Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal system. The most life-threatening complication of MFS is progressive aortic root dilation leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1) antagonist, is a drug already in clinical use for hypertension and type II diabetic nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Losartan and Atenolol or PropranololIn combination therapy,the maximal dose of Losartan is 100 mg/day for adult and 50 mg/day for children. 50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children |
| A | Active comparator | Drug: Atenolol or PropranololThe maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Marfan syndrome with recognized aortic root dilation
- Patients must be older than one year of age
- Beta-blocker treatment at least three months
- Must sign an informed consent form
Key exclusion criteria (6 listed)
- Prior to aortic root surgery
- Aortic root dimension more than 5.5cm
- Aortic surgery within 6 months
- Diabetes mellitus or liver and renal dysfunction or asthma
- Pregnancy
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 |
|---|---|---|
| Losartan and Atenolol or PropranololAlso: Cozaar and Tenormin or Inderal50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children. Losartan is 100 mg/day for adult and 50 mg/day for children. | Drug | B |
| Atenolol or PropranololAlso: Tenormin or InderalThe maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children. | Drug | A |
Primary outcome
Echocardiograms
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- Derived from this study: PubMed 23321647Chiu HH, Wu MH, Wang JK, Lu CW, Chiu SN, Chen CA, Lin MT, Hu FC. Losartan added to beta-blockade therapy for aortic root dilation in Marfan syndrome: a randomized, open-label pilot study. Mayo Clin Proc. 2013 Mar;88(3):271-6. doi: 10.1016/j.mayocp.2012.11.005. Epub 2013 Jan 12.
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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.
Mei-Hwan Wu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Losartan and Atenolol or Propranolol and Atenolol or Propranolol in people with Marfan Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 6 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 9 Jun 2010. 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Hsin-Hui Chiou (886-2-2312-3456 ext. 3160, eliachiou@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiograms (time frame: 4 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 NCT00651235, which also lists 1 linked publication.
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 9 Jun 2010.