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Evaluation of the Efficacy of Valsartan in Slowing Down Aortic Root Dilatation in Children and Young Adults with Marfan-type Heritable Thoracic Aortic Diseases – Valsar-TAD, a randomised, double-blind, placebo-controlled multicentre trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515059-39-00
Acronym
NBK154/2/2021
Enrollment
180
Registered
2024-11-11
Start date
2024-02-09
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Marfan Syndrome Diseases related to Marfan syndrome (rare diseases with aneurysms of the thoracic aorta and dissection of the aorta), among others: Loeys-Dietz syndrome, Vascular type of Ehlers-Danlos syndrome, Arterial Tortuosity syndrome, Shprintzen-Goldberg syndrome, Neonatal form of Marfan syndrome, Aneurysms-osteoarthritis syndrome, Multi-system smooth muscle dysfunction syndrome, Familial thoracic aortic aneurysms and aortic dissections, etc.

Brief summary

Absolute annual difference in aortic t diameter measured by transthoracic echocardiography and expressed in mm/yearroo

Detailed description

- annual difference in the aortic root diameter expressed in z-scores, indexed to sex and body surface area (BSA), measured by transthoracic echocardiography and expressed as z-score/year, - the absolute annual difference in aortic root diameter expressed in millimetres as assessed by angio- CT

Interventions

DRUG80 mg
DRUGtabletki
DRUGPL1
DRUGVALZEK
DRUGValsacor® 40 mg Filmtabletten
DRUGPL2

Sponsors

Medical University Of Gdansk
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Absolute annual difference in aortic t diameter measured by transthoracic echocardiography and expressed in mm/yearroo

Secondary

MeasureTime frame
- annual difference in the aortic root diameter expressed in z-scores, indexed to sex and body surface area (BSA), measured by transthoracic echocardiography and expressed as z-score/year, - the absolute annual difference in aortic root diameter expressed in millimetres as assessed by angio- CT

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026