ID as a Promoter of IH-induced CAVD

Not yet recruiting

• Conditions: Iron Deficiencies; Calcified Aortic Valve

• Registration Number: NCT06200870
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-05
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Study Start: 2024-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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