Dapagliflozin (DAPA) Effects in HFpEF

Overview

About this study

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.

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:

  • 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.

 

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Closed for enrollment

Contact information:

Nicole Reinicke

(507) 422-0780

Knutson.Nicole1@mayo.edu

More information

Publications

Publications are currently not available