Losartan and Marfan syndrome

Losartan therapy in patents with Marfan syndrome

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25140

Enrollment

330

Registered

2008-08-26

Start date

2008-02-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marfan syndrome - Marfan syndroom losartan aneurysma aorta

Interventions

- MRI scan or if contraindicated, CT scan - Echcardiography - Bloodsampling - Skin biopsy - SF-36 quality of life questionnaire

Eligibility

Inclusion criteria

Inclusion criteria: 1. Marfan syndrome diagnosed according to Ghent criteria

Exclusion criteria

Exclusion criteria: 1. More than one vascular prosthesis for the primary end-point evaluation. 2. Aortic root dimension > 5 cm. 3. Not-treated hypertension 4. Blood pressure higher than 160/90 mmHg 5. Blood pressure lower than 90/60 6. Taking ACE inhibitors and/or Angiotensine II receptor antagonists for other indications than prevention of aortic growth. 7. Planned aortic surgery within the 6 months of study entry. 8. Incapable of giving informed consent. 9. Hypersensitivity to losartan or any of its additional substances. 10. History of angioedema while taking an ACE inhibitor. 11. Hypersensitivity to intravenous contrast agent. 12. Shprintzen-Goldberg syndrome. (clinical features listed in App. II will be evaluated) 13. Loeys-Dietz syndrome. (clinical features listed in App. II will be evaluated) 14. Known bilateral renal artery stenosis. 15. Myocardial infarction, stroke or open-heart surgery in the previous four weeks. 16. Renal dysfunction ( creatinine level > 130 ug/ml) 17. Pregnancy (a pregnancy test is offered to every female patient within the fertile age assigned to losartan), nursing or planned pregnancy within 36 months of enrollment.

Design outcomes

Primary

Measure	Time frame
Largest change in absolute aortic diameter evaluated at all aortic levels in one patient: losartan group versus not-treated control group measured with MRA or Multi-slice CT.	—

Secondary

Measure	Time frame
• Change in mortality, incidence of newly diagnosed dissection in any main vessel and incidence of elective aortic surgery combined with the primary endpoint. • Change of aortic volume measured by MRA. • Change of aortic wall stiffness measured by MRA. • Change of left ventricular size and ejection fraction measured with MRI. • Prediction model for aortic growth. • Prediction model for treatment response to losartan therapy based on multiple biochemical, immunohystological and expression biomarkers. • Change in the quality of life scores.	—

Measure

Time frame

• Change in mortality, incidence of newly diagnosed dissection in any main vessel and incidence of elective aortic surgery combined with the primary endpoint. • Change of aortic volume measured by MRA. • Change of aortic wall stiffness measured by MRA. • Change of left ventricular size and ejection fraction measured with MRI. • Prediction model for aortic growth. • Prediction model for treatment response to losartan therapy based on multiple biochemical, immunohystological and expression biomarkers. • Change in the quality of life scores.

—

Contacts

Public ContactT. Radonic

Academic Medical Center Amsterdam Meibergdreef 9

t.radonic@amc.nl+31 (0)20 5666948

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)