drugset / Trial / NCT04385589
Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure
RandomizedSequentialDouble-blindTreatment
Summary
We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes.
Timeline
- Start
- 2020-05-01
- Primary completion
- 2020-12-15
- Completion
- 2020-12-20
Publications
- Background Ohara K, Masuda T, Morinari M, Okada M, Miki A, Nakagawa S, Murakami T, Oka K, Asakura M, Miyazawa Y, Maeshima A, Akimoto T, Saito O, Nagata D. The extracellular volume status predicts body fluid response to SGLT2 inhibitor dapagliflozin in diabetic kidney disease. Diabetol Metab Syndr. 2020 May 1;12:37. doi: 10.1186/s13098-020-00545-z. eCollection 2020.
- Background Elsisi GH, Anwar MM, Khattab M, Elebrashy I, Wafa A, Elhadad H, Awad M, Carapinha JL. Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt. J Med Econ. 2020 Aug;23(8):908-914. doi: 10.1080/13696998.2020.1764571. Epub 2020 May 28.
- Background Linden K, Mailey J, Kearney A, Menown IBA. Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials. Adv Ther. 2020 Jun;37(6):2620-2645. doi: 10.1007/s12325-020-01355-5. Epub 2020 May 2.
- Background Cappetta D, De Angelis A, Ciuffreda LP, Coppini R, Cozzolino A, Micciche A, Dell'Aversana C, D'Amario D, Cianflone E, Scavone C, Santini L, Palandri C, Naviglio S, Crea F, Rota M, Altucci L, Rossi F, Capuano A, Urbanek K, Berrino L. Amelioration of diastolic dysfunction by dapagliflozin in a non-diabetic model involves coronary endothelium. Pharmacol Res. 2020 Jul;157:104781. doi: 10.1016/j.phrs.2020.104781. Epub 2020 Apr 28.
- Kasem SM, Saied GM, Hegazy ANM, Abdelsabour M. Impact of Acute Insulin Resistance on Myocardial Blush in Non-Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention. Front Cardiovasc Med. 2021 May 10;8:647366. doi: 10.3389/fcvm.2021.647366. eCollection 2021.
- Ibrahim A, Ghaleb R, Mansour H, Hanafy A, Mahmoud NM, Abdelfatah Elsharef M, Kamal Salama M, Elsaughier SM, Abdel-Wahid L, Embarek Mohamed M, Ibrahim AK, Abdel-Galeel A. Safety and Efficacy of Adding Dapagliflozin to Furosemide in Type 2 Diabetic Patients With Decompensated Heart Failure and Reduced Ejection Fraction. Front Cardiovasc Med. 2020 Dec 7;7:602251. doi: 10.3389/fcvm.2020.602251. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dapagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Insulin | Protein / enzyme biologic | — | Subcutaneous |