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ID as a Promoter of IH-induced CAVD

Iron Deficiency as a Promoter of Intra-leaflet Haemorrhage-induced Aortic Valve Calcification

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06200870
Enrollment
3000
Registered
2024-01-11
Start date
2024-01-01
Completion date
2024-01-01
Last updated
2024-01-11

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

Conditions

Calcified Aortic Valve, Iron Deficiencies

Brief summary

Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Valvular interstitial cells (VICs) control the structure and function of aortic valve. Intra-leaflet haemorrhage (IH), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. In line with this, later exploration from vitro showed that iron stimulation alone could not promote VICs calcification. Iron deficiency (ID) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as CAVD; up to 50% of patients with severe aortic stenosis present ID. Data from a small clinical study in patients undergoing TAVI showed those in ID status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between ID and aortic valve remodelling and dysfunction progress itself. Here, the investigators aim to investigate for a tentative correlation between ID and human aortic valve remodeling and dysfunction.

Interventions

None listed

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* if performed with both color doppler echocardiography and anemia profile on admission as part of routine checkup.

Exclusion criteria

* if younger than the age of 18; * if no anemia profile or doppler echocardiography was measured; * if anemia profile or doppler echocardiography was analyzed in external laboratories; * if had a history of rheumatic heart disease, infective endocarditis or any other congenital disorders that may implicate aortic valve structures, such as bicuspid aortic valve morphology, Marfan syndrome, and so on.

Design outcomes

Primary

MeasureTime frameDescription
Serum ironwithin 24 hours of admissionPlasma levels of serum iron will be reported in μmol/L.
Total iron binding capacitywithin 24 hours of admissionTotal iron binding capacity will be reported in μmol/L.
Serum transferrin receptorwithin 24 hours of admissionPlasma levels of serum transferrin receptor will be reported in g/L.
Unsaturated iron-binding capacitywithin 24 hours of admissionSerum iron and total iron binding capacity will be combined to report unsaturated iron-binding capacity in μmol/L.
Serum transferrinwithin 24 hours of admissionPlasma levels of serum transferrin will be reported in g/L.
Transferrin saturationwithin 24 hours of admissionSerum iron and total iron binding capacity will be combined to report transferrin saturation in %.
Soluble transferrin indexwithin 24 hours of admissionSerum iron and serum transferrin will be combined to report soluble transferrin index.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026