Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial

Diabetes Care. 2020 Jun;43(6):1356-1359. doi: 10.2337/dc19-2187. Epub 2020 Apr 3.

Abstract

Objective: To determine the effects of dapagliflozin in patients with heart failure (HF) and type 2 diabetes mellitus (T2DM) on left ventricular (LV) remodeling using cardiac MRI.

Research design and methods: We randomized 56 patients with T2DM and HF with LV systolic dysfunction to dapagliflozin 10 mg daily or placebo for 1 year, on top of usual therapy. The primary end point was difference in LV end-systolic volume (LVESV) using cardiac MRI. Key secondary end points included other measures of LV remodeling and clinical and biochemical parameters.

Results: In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling. However, it reduced diastolic blood pressure and loop diuretic requirements while increasing hemoglobin, hematocrit, and ketone bodies. There was a trend toward lower weight.

Conclusions: We were unable to determine with certainty whether dapagliflozin in patients with T2DM and HF had any effect on LV remodeling. Whether the benefits of dapagliflozin in HF are due to remodeling or other mechanisms remains unknown.

Trial registration: ClinicalTrials.gov NCT02397421.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzhydryl Compounds / pharmacology
  • Benzhydryl Compounds / therapeutic use*
  • Cohort Studies
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / physiopathology
  • Diabetic Angiopathies / drug therapy
  • Diabetic Angiopathies / physiopathology
  • Female
  • Glucosides / pharmacology
  • Glucosides / therapeutic use*
  • Heart Failure / drug therapy*
  • Heart Failure / etiology
  • Heart Ventricles / drug effects
  • Heart Ventricles / pathology
  • Heart Ventricles / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Stroke Volume / drug effects
  • Ventricular Dysfunction, Left / drug therapy
  • Ventricular Dysfunction, Left / etiology
  • Ventricular Dysfunction, Left / physiopathology
  • Ventricular Remodeling / drug effects*
  • Ventricular Remodeling / physiology

Substances

  • Benzhydryl Compounds
  • Glucosides
  • Placebos
  • dapagliflozin

Associated data

  • ClinicalTrials.gov/NCT02397421