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) studied | Asymptomatic Heart Failure |
| Date of first enrollment | 31/01/2025 |
| Target sample size | 186 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Change in serum magnesium levels from baseline to 24 weeks after enrollment |
|---|---|
| Secondary Outcome | Association 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 maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients who were enrolled in the DAPA-EAT study at Wakayama Medical University Hospital and were followed up for 24 weeks. |
| Exclude criteria | Patients 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
| Primary Sponsor | Araki Shin-ichi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Kosuke Osawa |
| Address | 811-1 Kimiidera, Wakayama City, Wakayama Prefecture Wakayama Japan 641-8509 |
| Telephone | +81-73-441-0639 |
| 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 |
| araki@wakayama-med.ac.jp | |
| Affiliation | Wakayama Medical University |