ID as a Promoter of IH-induced CAVD

Iron Deficiencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06200870
• Other study ID #: 2023IDCAVD-LCB
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Calcified Aortic Valve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum iron	Plasma levels of serum iron will be reported in µmol/L.	within 24 hours of admission
Primary	Total iron binding capacity	Total iron binding capacity will be reported in µmol/L.	within 24 hours of admission
Primary	Serum transferrin receptor	Plasma levels of serum transferrin receptor will be reported in g/L.	within 24 hours of admission
Primary	Unsaturated iron-binding capacity	Serum iron and total iron binding capacity will be combined to report unsaturated iron-binding capacity in µmol/L.	within 24 hours of admission
Primary	Serum transferrin	Plasma levels of serum transferrin will be reported in g/L.	within 24 hours of admission
Primary	Transferrin saturation	Serum iron and total iron binding capacity will be combined to report transferrin saturation in %.	within 24 hours of admission
Primary	Soluble transferrin index	Serum iron and serum transferrin will be combined to report soluble transferrin index.	within 24 hours of admission