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NCT03883490: ELASTIC-AS
Role of Elastin Metabolites in Aortic Remodelling in AS
trial testing ECG in Aortic Stenosis in 46 participants. Completed in 31 August 2023.
31 August 2023
Quick facts
| Lead sponsor | University of Leicester |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 46 |
| Start date | 27 June 2019 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- ECG
- Blood test and biobanking
- Trans-thoracic Echocardiogram
- Vicorder recording
- Magnetic Resonance Imaging
Conditions studied
- Aortic Stenosis — all drugs for Aortic Stenosis →
Sponsor
University of Leicester
Who can join
18 and older, any sex, with Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. It is also more common for them to develop enlargement of the main blood vessel coming out of the heart, the aorta, and some studies suggest that they are also at higher risk of life-threatening tears in the aortic wall. Current guidelines recommend surgical replacement of the aorta at an earlier stage in these patients. The exact mechanism for the dilatation is not clear, and some studies have suggested greater 'stiffness' in the wall of the aorta. In this study, the investigators propose to 1.) study aortic size, stiffness and flow patterns using MRI in patients with bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in patients' blood that may be important in the process of expansion, 3.) compare the change in MRI and blood markers at before and 12 months after surgery, in patients who are due to have aortic valve replacement surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03883490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03883490 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Leicester
- Last refreshed: 20 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03883490.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing