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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2025-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Acute and Chronic Empagliflozin Heart Failure

NCT05553938

Heart Failure

RECRUITING PHASE1

Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

NCT02653482

Chronic Heart Failure With Reduced Systolic Function

COMPLETED PHASE4

Dapagliflozin in PRESERVED Ejection Fraction Heart Failure

NCT03030235

Chronic Heart Failure With Preserved Systolic Function

COMPLETED PHASE4

Short-term Effects of Dapagliflozin on Peak VO2 in HFrEF

NCT04197635

Heart Failure With Reduced Ejection Fraction

COMPLETED PHASE4

Empagliflozin in Hypertrophic Cardiomyopathy

NCT05182658

Hypertrophic Cardiomyopathy Heart Failure

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dapagliflozin 10 mg once daily

Group Type EXPERIMENTAL

Dapagliflozin 10 mg

Intervention Type DRUG

The intervention arm consists of dapagliflozin 10 mg orally once daily

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The comparator arm consists of placebo orally once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin 10 mg

The intervention arm consists of dapagliflozin 10 mg orally once daily

Intervention Type DRUG

Placebo

The comparator arm consists of placebo orally once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No