Research Highlights:

  • New data found that four out of five patients with heart failure with reduced ejection fraction, with or without type 2 diabetes, could be considered for treatment with the SGLT2 inhibitor dapagliflozin, the most recent therapy approved by the US FDA for this high-risk population.
  • The study evaluated records of more than 150,000 patients with heart failure in the U.S. leveraging contemporary data from the American Heart Association’s Get With The Guidelines–Heart Failure Registry.
  • These findings identify a significant population of patients with heart failure who may be candidates for this recent therapeutic advance.

Embargoed until 9 a.m. CT/10 a.m. ET Friday, Nov. 13, 2020

DALLAS, Nov. 13, 2020 — Analysis of data from a dedicated heart failure registry reveals four out of five patients with heart failure with reduced ejection fraction (HFrEF) could be considered for treatment with dapagliflozin, an sodium glucose co-transporter-2 (SGLT2) inhibitor, according to an analysis to be presented at the American Heart Association’s Scientific Sessions 2020. The meeting will be held virtually, Friday-Tuesday, November 13-17, 2020, and is a premier global exchange of the latest scientific advancements, research, and evidence-based clinical practice updates in cardiovascular science for health care worldwide. The study will be published simultaneously today in JAMA Cardiology.

“Despite accelerating scientific discoveries, few patients with heart failure are being treated with the best available treatment options in 2020,” said Muthiah Vaduganathan, M.D., M.P.H., first author of the study, a cardiologist at Brigham and Women’s Hospital and faculty at Harvard Medical School. “While SGLT2 inhibitors were first developed for treatment of diabetes, these therapies have now been recognized to reduce mortality, prevent worsening heart failure events, and improve health-related quality of life in patients with HFrEF, including among those without diabetes.”

Clinical trials evaluating novel therapies are often conducted in highly selected groups of patients, raising questions regarding the applicability of the trial results to “real world” patients in clinical practice. The objective of the study was to determine the proportion of patients with heart failure who would meet eligibility for treatment with dapagliflozin, as outlined by the U.S. Food and Drug Administration’s May 2020 approval of dapagliflozin for patients with HFrEF. While SGLT2 inhibitors were initially developed for the management of type 2 diabetes, dapagliflozin is the first SGLT-2 inhibitor to be approved for use for heart failure, irrespective of diabetes status[1][2][3].

The study evaluated data from over 150,000 patients hospitalized for HFrEF at over 400 hospital centers across the U.S. participating in the American Heart Association’s Get with The Guidelines®-Heart Failure (GWTG-HF) quality improvement initiative from 2014 to 2019. The researchers found:

  • 80% of patients in the registry met the FDA criteria for HF treatment with dapagliflozin;
  • A similarly high proportion of patients with type 2 diabetes (~75%) and without type 2 diabetes (~85%) met eligibility criteria;
  • Advanced kidney disease (eGFR<30 mL/min/1.73 m2) was the most common reason for not being a dapagliflozin candidate
  • Treatment candidates identified in the GWTG-HF registry shared many clinical characteristics with participants enrolled in DAPA-HF,3 the pivotal trial that established the efficacy and safety of dapagliflozin in HFrEF

“These data support the broad generalizability of recent trial findings evaluating the SGLT2 inhibitors to U.S. clinical practice,” said Gregg C. Fonarow, M.D., senior author of the study, interim chief of the division of cardiology, director of the Ahmanson-UCLA Cardiomyopathy Center, co-director of the Preventative Cardiology Program, and the Eliot Corday Chair in Cardiovascular Medicine and Science at the University of California, Los Angeles. “The SGLT2 inhibitors are now established as a new pillar of care for patients with heart failure. We must now rapidly translate this knowledge to practice to improve patient outcomes.”

This study is the first in a series of six studies under the TRANSLATE-HF research platform, commissioned by the American Heart Association in collaboration with AstraZeneca and focused on evidence-based treatment for patients with heart failure. The research series will utilize data from the Association’s GWTG-HF registry to address critical knowledge gaps and potential barriers to prescribing the latest, evidence-based therapies for patients diagnosed with heart failure. Findings from the TRANSLATE-HF platform will also help to identify potential areas for increasing implementation efforts that can improve quality of care delivery, and ultimately, patient outcomes.

The TRANSLATE-HF umbrella will link the large GWTG-HF population with multiple streams of claims data from the Centers for Medicare & Medicaid Services to track patients during their longitudinal journey during and after hospitalization for heart failure. The TRANSLATE-HF series is a collaboration overseen by an independent, volunteer Steering Group, and the research platform is funded by AstraZeneca. The GWTG-HF program is provided by the American Heart Association. GWTG-HF is supported, in part, by Novartis, Boehringer Ingelheim Lilly, Novo Nordisk, Sanofi, AstraZeneca, and Bayer.

Authors of this first study include the TRANSLATE-HF lead investigators, Drs. Vaduganathan and Fonarow, together with Stephen J. Greene, M.D.; Shuaiqi Zhang, M.S.; Maria Grau-Sepulveda, M.D.; Adam D. DeVore, M.D., M.H.S.; Javed Butler, M.D., M.P.H., M.B.A.; Paul A. Heidenreich, M.D.; Joanna C. Huang, Pharm.D.; Michelle M. Kittleson, M.D., Ph.D.; Karen E. Joynt Maddox, M.D., M.P.H.; James J. McDermott, Ph.D.; Anjali Tiku Owens, M.D.; Pamela N. Peterson, M.D., M.P.H., M.S.P.H.; Scott D. Solomon, M.D.; Orly Vardeny, Pharm.D.; and Clyde W. Yancy, M.D. M.Sc. Author disclosures are in the abstract. All statistical analyses were conducted independently at Duke Clinical Research Institute.

Note: Link to presentation

Additional Resources:

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[1] McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019; 381(21):1995-2008.

[2] Vaduganathan M, Butler J. SGLT-2 inhibitors in heart failure: a new therapeutic avenue. Nat Med. 2019; 25(11):1653-4

[3] Petrie MC, Verma S, Docherty KF, et al. Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients with Heart Failure with and Without Diabetes. JAMA. 2020; 323(14):1353-1368.