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NCT06066632: CAUSATIVE
Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
trial in Amyloidosis Cardiac in 480 participants. Status unknown.
1 May 2024
Quick facts
| Lead sponsor | University Hospital of Ferrara |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 480 |
| Start date | 1 June 2023 |
| Primary completion | 1 May 2024 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across Italy |
Conditions studied
- Amyloidosis Cardiac — all drugs for Amyloidosis Cardiac →
- Aortic Stenosis, Severe — all drugs for Aortic Stenosis, Severe →
Sponsor
University Hospital of Ferrara
Who can join
65 and older, any sex, with Amyloidosis Cardiac or Aortic Stenosis, Severe. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree. In patients with dual pathology (AS + CA) the most frequent AS hemodynamic profile is paradoxical low-flow, low-gradient AS. In this setting, estimating stenosis degree with cardiac ultrasound may be challenging and aortic valve calcium score estimation by cardiac CT is a valuable exam. Preliminary findings from small case series showed that patients with severe AS and CA presented less valvular calcium deposition compared to patients with severe AS alone. On this basis, confirmation of these findings would have a huge clinical impact on diagnosis, choice of treatment strategy and understanding of the pathophysiology of these patients. The aim of the study is to study the correlation between valvular calcium score (assessed by EKG-gated CT) and effective orifice area (assessed through echocardiogram) according to cardiac amyloidosis presence (in the overall population and among hemodynamic phenotypes of cardiac amyloidosis). As secondary endpoints the study will sought to assess TAVI/SAVR efficacy, procedural complications, in-hospital mortality, all-cause death and heart failure hospitalization at 1 year, according to absence or presence of CA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06066632
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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Other University Hospital of Ferrara trials
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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 NCT06066632 (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 Hospital of Ferrara
- Last refreshed: 4 October 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/NCT06066632.
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