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Recruiting NCT05359263

Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD

Phase II Interventional Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin 10 mg, Placebo.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The study is a 6-month, investigator-initiated, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. The study population will consist of approximately 222 adults with chronic kidney disease - defined as a glomerular filtration rate (GFR) of 20-60 mL/min/1.73m2, in treatment with maximally tolerated ACEi or ARB. Patients will be randomized to either 10 mg dapagliflozin or placebo. Patients will be assessed by measurement of echocardiography, pulse wave velocity, blood samples, urine samples, quality of life, depressive symptoms, and cognitive function at baseline and after 6 months of treatment.

Interventions

  • Drug Dapagliflozin 10 mg
    The intervention arm consists of dapagliflozin 10 mg orally once daily
  • Drug Placebo
    The comparator arm consists of placebo orally once daily

Primary outcome measures

  • Change in LV mass index assessed by echocardiography at 6 months [Time frame: 6 months]
Secondary outcome measures (11)
  • Change in LVEF assessed by echocardiography at 6 months [Time frame: 6 months]
  • Change in LA volume index assessed by echocardiography at 6 months [Time frame: 6 months]
  • Change in GLS assessed by echocardiography at 6 months [Time frame: 6 months]
  • Change in high sensitivity troponin I (hs-TNI) at 6 months [Time frame: 6 months]
  • Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months [Time frame: 6 months]
  • Change in estimated glomerular filtration rate (eGFR) 6 months [Time frame: 6 months]
  • Change in urinary albumin-to-creatinine ratio (UACR) at 6 months [Time frame: 6 months]
  • Change in hemoglobin at 6 months [Time frame: 6 months]
  • Change in LV mass assessed by echocardiography at 6 months [Time frame: 6 months]
  • Change in LV end-diastolic volume at 6 months [Time frame: 6 months]
  • Change in LV end-systolic volume at 6 months [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Signed informed consent
  • ≥ 18 years of age
  • Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and <60 mL/minute per 1.73 m2) or between eGFR ≥60 and <90 mL/minute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg/g or protein:creatinine ratio ≥300 mg/g
  • Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated
  • For patients with type 2 diabetes:

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 criteria

  • Type 1 diabetes
  • For patients with type 2 diabetes:

History of diabetic ketoacidosis

  • Patients undergoing dialysis
  • History of organ transplant
  • Treatment with SGLT2 inhibitor within 8 weeks 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
  • 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)
  • 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.
  • Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion
  • Participation in another clinical study with an investigational product within the last month prior to enrolment
  • Inability to understand or comply with the investigational product, procedures, and/or follow-up or any conditions that may prevent the participant to complete the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Gentofte Hospital — Copenhagen

Publications

  • Bartholdy KV, Johansen ND, Skaarup KG, Modin D, Landler N, Langhoff AF, Ottosen CI, Espersen C, Dons M, Borchsenius JIM, Davodian LW, Lassen MH, Davidovski FS, Jensen AMR, Sengelov M, Christensen J, Schou M, Feldt-Rasmussen B, Jensen J, Bressendorff I, Persson F, Rossing P, Kober L, Zannad F, Vaduganathan M, Solomon S, Haynes R, Hansen D, Biering-Sorensen T. Cardiac Effects of Dapagliflozin in Peo PMID 41147829
  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2. PMID 38770818
  • Bartholdy KV, Johansen ND, Landler N, Skaarup KG, Jensen J, Bressendorff I, Schou M, Christensen J, Feldt-Rasmussen B, Vaduganathan M, Solomon S, Haynes R, Persson F, Rossing P, Kober L, Zannad F, Hansen D, Biering-Sorensen T. Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease: The DECODE-CKD Trial. Kidney360. 2023 Feb 1 PMID 36649484

Identifiers

NCT: NCT05359263 · DECODE-CKD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗