ID as a Promoter of IH-induced CAVD

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Calcified Aortic Valve; Iron Deficiencies

• Study Type: Observational
• Enrollment (Estimated): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients at the outpatient clinic or inpatient department, Qilu hospital of Shandong University, Jinan, were recruited during the period from January 2018 to March 2023.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
aortic valvular sclerosis group
non-aortic valvular sclerosis group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Iron Deficiencies
• Other Study ID Numbers: 2023IDCAVD-LCB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Limited by the submitted ethical protocols

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No