Actively Recruiting
Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD
Led by Tor Biering-Sørensen · Updated on 2025-02-10
222
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.
CONDITIONS
Official Title
Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- At least 18 years old
- Chronic kidney disease with eGFR between 20 and less than 60 mL/min/1.73 m2, or eGFR 60 to less than 90 mL/min/1.73 m2 with high urinary protein
- Stable treatment with maximally tolerated doses of ACE inhibitors or ARBs for at least 4 weeks before starting
- For type 2 diabetes patients: stable antihyperglycemic treatment for more than 30 days before screening
- Female participants must be postmenopausal for at least 1 year, surgically sterile, or use effective contraception during the study and for 30 days after
- Ability to understand and read Danish
You will not qualify if you...
- Type 1 diabetes
- For type 2 diabetes patients: history of diabetic ketoacidosis
- Currently receiving dialysis
- History of organ transplant
- Treatment with SGLT2 inhibitors within 8 weeks before the study
- Allergy or sensitivity to SGLT2 inhibitors or placebo ingredients
- Heart attack, unstable angina, stroke, or transient ischemic attack within 12 weeks before the study
- Coronary or valve surgery within 12 weeks before the study
- Life expectancy under 2 years from non-renal or cardiovascular causes
- Liver impairment with high liver enzyme or bilirubin levels at enrollment
- Known blood-borne infections such as hepatitis or HIV
- Pregnant, breastfeeding, or planning pregnancy during the study or 6 months after
- Participation in another clinical trial with investigational drugs in the last month
- Inability to understand or follow study procedures or complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gentofte Hospital
Copenhagen, Denmark, 2900
Actively Recruiting
Research Team
K
Katja Vu Bartholdy, MD
CONTACT
N
Niklas Dyrby Johansen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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