A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD)
Key facts
- Where
- Hellerup és Herlev, DániaSee the 2 sites
- Phase
- 1/2. fázis
Where in Dánia
- Gentofte HospitalHellerup, DániaToborzás még nem indult
- Herlev og Gentofte Hospital, Region HHerlev, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gentofte Hospital
- Trial code
- EU 2024-517040-65-02
- Record updated
- 2025. január 29.
- Original description
The study will provide a comprehensive view of the effect of dapagliflozin on cardiac structural changes, as well as the effect on systolic and diastolic cardiac function, in patients with all stages of CKD of different etiology.Read full original descriptionShow less
The study will provide a comprehensive view of the effect of dapagliflozin on cardiac structural changes, as well as the effect on systolic and diastolic cardiac function, in patients with all stages of CKD of different etiology.
Inclusion: Signed informed consent; ≥ 18 years of age; For those not undergoing dialysis: o Chronic Kidney Disease (CKD), defined as evidence of decreased eGFR (eGFR >=20 and <60 mL/min/1.73 m2) at least 3 months before and at the time of screening or evidence of albuminuria present for > 3 months if eGFR >60; For those undergoing hemodialysis: Initiation of hemodialysis within 1 year of the randomization visit; Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria, if not medically contraindicated; For patients with type 2 diabetes: o Stable antihyperglycemic treatment > 30 days before screening; Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device; Ability to understand and read Danish.
Exclusion: Type 1 diabetes; For dialysis participants: Known hepatic impairment documented in the participants electronic health record; Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus; For patients with type 2 diabetes: o History of diabetic ketoacidosis; History of organ transplant; Treatment with SGLT2 inhibitor within 8 weeks (not undergoing dialysis) or 4 weeks (undergoing dialysis) prior to enrolment; Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients; Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment; Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment; Any condition outside the renal and cardiovascular study area with a life expectancy of <2 years based on investigator’s clinical judgement; For non-dialysis participants: Hepatic impairment (aspartate transaminase or alanine transaminase >3 times the upper limit of normal [ULN] or total bilirubin >2 times the ULN at the time of enrolment).