Dapagliflozin (DAPA) Effects in HFpEF

Overview

Información sobre este estudio

The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.

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:

  • Signed informed consent prior to any study specific procedures.
  • Male or female subject.
  • Age ≥ 18.
  • Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.
  • EF ≥ 50%.
  • Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.

Exclusion Criteria:

  • Type I diabetes.
  • Type II diabetes with poor control (HgbA1c ≥ 10%).
  • Recent hospitalization (< 30 days) or revascularization (< 90 days).
  • Primary cardiomyopathy (such as amyloid).
  • Constrictive pericarditis.
  • Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator.
  • Severe anemia (hemoglobin < 9 gm/dl).
  • Significant left-sided valvular heart disease (> moderate stenosis, > moderate regurgitation).
  • Severe kidney disease (estimated GFR < 30) or liver disease.
  • Women of child bearing potential not willing to use a medically accepted method of contraception OR who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
  • History of serious hypersensitivity reaction to dapagliflozin.
  • Subjects on dialysis.
  • Subjects with severe hepatic impairment (Child-Pugh class C).
  • Currently taking Empagliflozin or Canagliflozin.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

 

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 Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Barry Borlaug, M.D.

Cerrado para la inscripción

Contact information:

Nicole Reinicke

(507) 422-0780

Knutson.Nicole1@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20506720

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