CClinicalTrials.gg
Status unknownNCT00651235MFSUpdated Jun 9, 2010

A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome

A Phase 2 interventional study of Losartan and Atenolol or Propranolol and Atenolol or Propranolol in Marfan Syndrome, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2010-06-09.

Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
1 Year and older
Sex
All
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Study summary

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.

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Conditions studied

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In context

Marfan Syndrome

71 studies on the registry are indexed under Marfan Syndrome; 16 are open to participants now.

This study's planned enrollment of 44 is close to the median of 40 across 31 interventional studies indexed under Marfan Syndrome.

Browse Marfan Syndrome studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    B

    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

    Drug: Losartan and Atenolol or Propranolol

  • Active comparator
    A

    The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.

    Drug: Atenolol or Propranolol

Interventions

  • DrugLosartan and Atenolol or Propranolol

    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.

    Also known as: Cozaar and Tenormin or Inderal

  • DrugAtenolol or Propranolol

    The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.

    Also known as: Tenormin or Inderal

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What researchers measure

Primary outcomes

  1. Echocardiograms

    Time frame: 4 months

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Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00651235
Lead sponsor
National Taiwan University Hospital
First posted
Apr 2, 2008
Start date
Feb 2007
Primary completion
Feb 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Jun 9, 2010

Study contacts

Hsin-Hui Chiou
Contact
eliachiou@yahoo.com.tw
886-2-2312-3456 ext. 3160
Mei-Hwan Wu
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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