Cardiac Effects of Dapagliflozin in People with Chronic Kidney Disease.
Katja Vu Bartholdy, Niklas Dyrby Johansen, Kristoffer Grundtvig Skaarup...
https://pubmed.ncbi.nlm.nih.gov/41147829Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05359263
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
Led by Tor Biering-Sørensen · Updated on 2025-02-10
222
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study how dapagliflozin affects heart structure and function in adults with chronic kidney disease. The study focuses on patients with a reduced kidney filtration rate who are already receiving treatment with ACE inhibitors or ARBs. It is a randomized, double-blind, placebo-controlled clinical trial lasting 6 months to explore changes in heart measures using echocardiography. Participants will be randomly assigned to receive either 10 mg of dapagliflozin or a placebo once daily for six months. The study includes detailed assessments at the start and end of the treatment period, including echocardiography, pulse wave velocity, blood and urine tests, and evaluations of quality of life, depressive symptoms, and cognitive function. During the study, participants will have their heart and kidney function monitored through various tests and questionnaires. The primary measure is the change in left ventricular mass index after 6 months. Secondary outcomes include changes in heart pumping ability, heart chamber sizes, blood markers of heart stress, kidney function, and other health indicators. The full participation time is six months, with careful monitoring throughout.
CONDITIONS
Brief Title
Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- 18 years of age or older
- Chronic kidney disease with eGFR between 20 and 60 mL/min/1.73 m2 or eGFR between 60 and 90 with elevated urinary albumin or protein
- Stable treatment with maximally tolerated doses of ACE inhibitors or ARBs for at least 4 weeks before randomization if not contraindicated
- For type 2 diabetes patients: stable antihyperglycemic treatment for more than 30 days before screening
- Female patients either not of childbearing potential or using specified contraception throughout the study and for 30 days after
- Ability to understand and read Danish
You will not qualify if you...
- Type 1 diabetes
- History of diabetic ketoacidosis for type 2 diabetes patients
- Patients undergoing dialysis
- History of organ transplant
- Use of SGLT2 inhibitors within 8 weeks prior to enrollment
- Known allergy or hypersensitivity to SGLT2 inhibitors or placebo ingredients
- Recent myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
- Recent coronary revascularization or valvular repair/replacement within 12 weeks prior to enrollment
- Any condition with life expectancy less than 2 years outside renal and cardiovascular areas
- Hepatic impairment with elevated liver enzymes or bilirubin at enrollment
- Known blood-borne diseases such as Hepatitis A-E, HIV types 1 and 2, Ebola, or Lassa fever
- Female patients who are pregnant, lactating, or planning pregnancy during the study or for 6 months after
- Participation in another investigational product study within the last month
- Inability to understand or comply with study procedures or follow-up requirements
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive dapagliflozin 10 mg or placebo orally once daily and are assessed for changes in cardiac structure and function.
Baseline visit and 1 follow-up visit at 6 months
Trial Site Locations
Total: 1 location
1
Gentofte Hospital
Copenhagen, Denmark, 2900
Actively Recruiting
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Research Team
K
Katja Vu Bartholdy, MD
N
Niklas Dyrby Johansen
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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Published Research Related To This Trial
Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
Patrizia Natale, David J Tunnicliffe, Tadashi Toyama...
https://pubmed.ncbi.nlm.nih.gov/38770818Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease: The DECODE-CKD Trial.
Katja Vu Bartholdy, Niklas Dyrby Johansen, Nino Landler...
https://pubmed.ncbi.nlm.nih.gov/36649484