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

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-000324
    NCT ID: NCT02653482
    Sponsor Protocol Number: D1690C00032

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. 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
  2. Hemoglobin A1c of 6.5-11.0% at enrollment
  3. 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
  4. No change in diuretic management for at least 2 weeks prior to enrollment
  5. BNP ≥125 pg/mL and/or NTproBNP ≥ 600 pg/mL at enrollment

Exclusion Criteria:

  1. History of type 1 diabetes
  2. Estimated glomerular filtration rate (eGFR) < 45 at enrollment
  3. Hospitalization for heart failure within the 60 days prior to enrollment
  4. 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
  5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
  6. 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
  7. Patients who are volume depleted based upon physical examination at the time of enrollment

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Horng Chen, M.D.

Closed for enrollment

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CLS-20271284

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