ID as a Promoter of IH-induced CAVD

NCT06200870 | Unknown

• 1 other identifier: 2023IDCAVD-LCB
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiencies; Calcified Aortic Valve

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

aortic valvular sclerosis group

non-aortic valvular sclerosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Iron Deficiencies; Aortic Valve, Calcification of

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: January 11, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share