Resveratrol as potential aortic growth inhibitor in patients with Marfan Syndrome

Resveratrol as potential aortic growth inhibitor in patients with Marfan Syndrome - RESVcue Marfan

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49268

Enrollment

100

Registered

2018-09-24

Start date

2018-12-10

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

connective tissue disease Marfan syndrome

Interventions

Resveratrol 500 mg/day for one year

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Marfan patients with a known FBN1 mutation - Between 18-50 years of age - Native aortic root (n

Exclusion criteria

Exclusion criteria: - More than one vascular prosthesis - Aortic root diameter > 45 mm - Aortic surgery likely within 6 months of inclusion - Aortic surgery in the last 6 months prior to inclusion - Aortic dissection - Contraindications for MR imaging - Mental retardation

Design outcomes

Primary

Measure	Time frame
There are three main study parameters/endpoints: 1. A decrease in aortic aneurysm expansion rate in > 90% of the study subjects as measured by echo between baseline (at timepoint of inclusion in the study) and after twelve months of follow-up (after resveratrol treatment). 2. Any statistical significant beneficial change in aortic elasticity or aortic wall shear rate as measured by magnetic resonance imaging (MRI) between baseline (at timepoint of inclusion in the study) and after twelve months of follow-up (after resveratrol treatment). 3. Any statistical significant beneficial change in endothelial function as measured by Flow Mediated Dilatation (FMD)	—

Measure

Time frame

There are three main study parameters/endpoints: 1. A decrease in aortic aneurysm expansion rate in > 90% of the study subjects as measured by echo between baseline (at timepoint of inclusion in the study) and after twelve months of follow-up (after resveratrol treatment). 2. Any statistical significant beneficial change in aortic elasticity or aortic wall shear rate as measured by magnetic resonance imaging (MRI) between baseline (at timepoint of inclusion in the study) and after twelve months of follow-up (after resveratrol treatment). 3. Any statistical significant beneficial change in endothelial function as measured by Flow Mediated Dilatation (FMD)

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Secondary

Measure	Time frame
1. To evaluate functional cardiac parameters by echocardiography in Marfan patients upon treatment with resveratrol. 2. To evaluate changes in blood pressure/heart rate in patients with Marfan syndrome treated with resveratrol. 3. To evaluate changes in endothelial cell function in patients with Marfan syndrome treated with resveratrol by flow mediated dilation measurement (FMD). 4. To evaluate differences between Marfan patients who have had aortic replacement and Marfan patients with a native aorta, before or after resveratrol. 5. To evaluate differences between Marfan patients who have a haploinsufficient (HI) FBN1 mutation or a dominant negative (DN) FBN1 mutation. Geneticists determine the HI or DN status, however, skin cultures may provide conclusive results when the mutation effect is unpredictable.	—

Measure

Time frame

1. To evaluate functional cardiac parameters by echocardiography in Marfan patients upon treatment with resveratrol. 2. To evaluate changes in blood pressure/heart rate in patients with Marfan syndrome treated with resveratrol. 3. To evaluate changes in endothelial cell function in patients with Marfan syndrome treated with resveratrol by flow mediated dilation measurement (FMD). 4. To evaluate differences between Marfan patients who have had aortic replacement and Marfan patients with a native aorta, before or after resveratrol. 5. To evaluate differences between Marfan patients who have a haploinsufficient (HI) FBN1 mutation or a dominant negative (DN) FBN1 mutation. Geneticists determine the HI or DN status, however, skin cultures may provide conclusive results when the mutation effect is unpredictable.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)