Cardiac Biomarkers and Iron Status in Hemodialysis Patients

NCT05256004 | Completed DMC

• 1 other identifier: 110070
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Peripheral arterial disease (PAD) a condition characterized by atherosclerotic occlusive disease of the lower extremities is commonly observed in patients with chronic kidney disease (CKD) patients, particularly those on dialysis. We conducted detailed biomarkers such as thrombospondin and related inflammatory biomarkers for the risk of developing and presence of PAD. Thrombospondin-4 (TSP-4) is an extracellular matrix protein of the vessel wall. Despite bench evidence, its significance in the clinical setting of chronic kidney disease (CKD) is missing Methods: This is a cross-sectional, single-center study. A cohort of 450 patients aged 20 or over, who have been on HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included. TSP-4 and TSP-1 will be measured in HD patients using a commercially available ELISA. PAD is diagnosed by the ankle-brachial index (ABI) We will measure related blood biomarkers such as serum hs-cTnT, N-terminal probrain natriuretic peptide, s-Klotho and FABP-4.

Conditions

Heart Failure; Iron-deficiency

Keywords

Heart failure; Iron status; Cardiac biomarkers

Outcome Measures

Primary Outcomes (1)

• Measures of iron status

  indicating iron storage (ferritin), iron transport (transferrin saturation), regulator of systemic iron homeostasis (hepcidin) and iron demand (soluble transferrin receptor) ,Iron dysmetabolism potentially contributes to heart failure

  1 years

Secondary Outcomes (6)

• Analysis of biomarkers of GDF-15

  1 years

• Analysis of biomarkers of Galectin-3

  1 years

• Analysis of biomarkers of Soluble ST2

  1 years

• Analysis of biomarkers of hs-cTnT

  1 years

• Analysis of biomarkers of N-terminal probrain natriuretic peptide

  1 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.

You may qualify if:

• Both sexes aged 20 years or over
• Received stable hemodialysis at least 3 months.
• Written informed consent.

You may not qualify if:

• decompensated cirrhosis.
• neoplastic diseases.
• incomplete data.
• receiving hemodialysis \< 3 months and active infection.

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

TW (1)