A Study of the Effect of Dapagliflozin on Symptoms and Biomarkers in Diabetes Patients with Heart Failure

Overview

About this study

The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients who have type 2 diabetes and chronic heart failure with reduced systolic function.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Documented type 2 diabetes for at least 6 months, treated with at least one glucose-lowering medication (oral, non-insulin injectables, or insulin) with a stable dose(s) during the 12 weeks prior to enrollment
Hemoglobin A1c of 6.5-11.0% at enrollment
Established diagnosis of NYHA Class II or Class III heart failure (LVEF≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
No change in diuretic management for at least 2 weeks prior to enrollment
BNP ≥125 pg/mL and/or NTproBNP ≥ 600 pg/mL at enrollment

Exclusion Criteria:

History of type 1 diabetes
Estimated glomerular filtration rate (eGFR) < 45 at enrollment
Hospitalization for heart failure within the 60 days prior to enrollment
Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 60 days prior to enrollment
Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy) within the 90 days after enrollment
Patients who are volume depleted based upon physical examination at the time of enrollment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Horng Chen, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Horng Chen, M.D.

Closed for enrollment

More information

Publications

Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown. Read More on PubMed

Clinical Trials