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JAPANESE
JRCT ID: jRCT1050240257

Registered date:31/01/2025

Dapagliflozin-Induced Serum Magnesium Changes and Lipid Profiles in Asymptomatic Heart Failure

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAsymptomatic Heart Failure
Date of first enrollment31/01/2025
Target sample size186
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeChange in serum magnesium levels from baseline to 24 weeks after enrollment
Secondary OutcomeAssociation between changes in serum magnesium levels (from baseline to 24 weeks) and the following parameters: (1)Change in epicardial adipose tissue (EAT) volume (2)Change in LDL cholesterol (LDL-C) levels (3)Change in non-HDL cholesterol (non-HDL-C) levels (4)Change in triglyceride (TG) levels

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients who were enrolled in the DAPA-EAT study at Wakayama Medical University Hospital and were followed up for 24 weeks.
Exclude criteriaPatients will be excluded if they meet any of the following criteria: 1)Patients with a history of taking SGLT2 inhibitors. 2)Patients with a history of hypersensitivity to dapagliflozin. 3)Patients with type 1 diabetes. 4)Patients with significant anemia (hemoglobin < 9 g/dL). 5)Patients whose serum AST/ALT/ALP levels exceed the specified limits (AST > 150 IU/L, ALT > 150 IU/L, ALP > 300 U/L). 6)Patients with severe renal failure (eGFR < 30 ml/min/1.73m2). 7)Patients receiving systemic steroid therapy (local administration is allowed). 8)Patients with a history of alcohol or drug abuse within the past 3 months. 9)Patients who had a urinary or genital tract infection within the past 2 weeks. 10)Patients with severe aortic valve stenosis. 11)Patients with symptomatic coronary artery disease. 12)Patients scheduled for cardiovascular surgery within 24 weeks after enrollment. 13)Patients with systolic blood pressure < 90 mmHg. 14)Patients who cannot undergo contrast-enhanced CT due to contrast agent allergies. 15)Pregnant or lactating women, or those planning to become pregnant. 16)Patients whom the principal investigator, responsible investigator, or sub-investigator deems inappropriate for study participation. 17)Patients who express their refusal to participate after the public disclosure of study information.

Related Information

Contact

Public contact
Name Kosuke Osawa
Address 811-1 Kimiidera, Wakayama City, Wakayama Prefecture Wakayama Japan 641-8509
Telephone +81-73-441-0639
E-mail k_osawa@wakayama-med.ac.jp
Affiliation Wakayama Medical University
Scientific contact
Name Shin-ichi Araki
Address 811-1 Kimiidera, Wakayama City, Wakayama Prefecture Wakayama Japan 641-8509
Telephone +81-73-441-0639
E-mail araki@wakayama-med.ac.jp
Affiliation Wakayama Medical University