ID as a Promoter of IH-induced CAVD

Shandong University

Status: Not yet enrolling

Conditions: Iron Deficiencies; Calcified Aortic Valve

Study type: Observational

Funder types: Other

Identifiers

NCT06200870

2023IDCAVD-LCB

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

aortic valvular sclerosis group

non-aortic valvular sclerosis group