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NCT05749107: ASTRA
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
trial testing Echocardiography in Heart Valve Incompetence in 1,050 participants. Status unknown.
2 December 2024
Quick facts
| Lead sponsor | Istituto Auxologico Italiano |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,050 |
| Start date | 2 December 2022 |
| Primary completion | 2 December 2024 |
| Estimated completion | 2 November 2025 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Echocardiography
- Proteomic analyses
Conditions studied
- Heart Valve Incompetence — all drugs for Heart Valve Incompetence →
- Atrial Fibrillation, Persistent — all drugs for Atrial Fibrillation, Persistent →
Sponsor
Istituto Auxologico Italiano — full company profile →
Who can join
18 and older, any sex, with Heart Valve Incompetence or Atrial Fibrillation, Persistent. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05749107
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
- NCT05747404 — The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study · recruiting
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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 NCT05749107 (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 Istituto Auxologico Italiano
- Last refreshed: 15 March 2024
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/NCT05749107.
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