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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Horng Chen, M.D.

Cerrado para la inscripción

More information

Publicaciones

  • 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

Otros temas en investigación

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CLS-20271284

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