Empagliflozin Evaluation by Measuring the Impact on Hemodynamics in Patients With Heart Failure - EMBRACE-HF

May 04, 2021
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Boehringer Ingelheim
Date Published:
02/09/2021
Date Updated:
05/04/2021
Original Posted Date:
05/04/2021
References

Contribution To Literature:

The EMBRACE-HF trial showed that empagliflozin significantly reduced average PA diastolic pressures at 8-12 weeks compared with placebo among patients with an implanted CardioMEMS PAP sensor due to difficult-to-manage HF with and without T2DM.

Description:

The goal of the trial was to assess the efficacy of empagliflozin in reducing pulmonary artery pressures (PAPs) among patients with heart failure (HF).

Study Design

Eligible patients were randomized in a 1:1 fashion to either empagliflozin 10 mg daily (n = 33) or placebo (n = 32). 

  • Total screened: 93
  • Total number of enrollees: 65
  • Duration of follow-up: 12 weeks
  • Mean patient age: 66 years
  • Percentage female: 37%

Inclusion criteria:

  • Patients with and without type 2 diabetes mellitus (T2DM)
  • Adult ambulatory
  • Established HF with reduced ejection fraction (HFrEF) or HF with preserved EF (HFpEF)
  • Previously implanted CardioMEMS device

Exclusion criteria:

  • Recent hospitalization (within 14 days) for decompensated HF
  • Recent changes (within 48 hours) in diuretic dose
  • Recent (within 4 weeks) initiation of hydralazine, long-acting nitrates, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers, or sacubitril/valsartan
  • Baseline PA diastolic pressure <12 mm Hg
  • Marked variability in PA diastolic pressure during screening period
  • Estimated glomerular filtration rate <30 ml/min/1.73 m2
  • Type 1 DM

Other salient features/characteristics:

  • Duration of HF: 6.3 years
  • Mean EF: 44%; EF ≤40%: 48%
  • New York Heart Association class III/IV: 54%
  • Mean PA diastolic pressure:  22 mm Hg

Principal Findings:

The primary outcome, change in average PA diastolic pressure between weeks 8-12 between empagliflozin vs. placebo, was -1.5 mm Hg (p = 0.02).

Secondary outcomes for empagliflozin vs. placebo:

  • ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) at 12 weeks: 34% vs. 33% (p = 0.72)
  • Mean adjusted N-terminal pro-B-type natriuretic peptide (NT-proBNP) at week 12: 659 vs. 802 pg/dl (p = 0.24)
  • Adjusted mean weight at week 12: 99.5 vs. 101.9 kg (p = 0.02)
  • Hemoglobin A1c at week 12: 6.8% vs. 6.3% (p = 0.05)

Interpretation:

The results of this small trial indicate that empagliflozin significantly reduced average PA diastolic pressures at 8-12 weeks compared with placebo among patients with an implanted CardioMEMS PAP sensor due to difficult-to-manage HF (with either HFrEF or HFpEF). No difference in patient-reported or clinical outcomes was noted.

References:

Nassif ME, Qintar M, Windsor SL, et al. Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial. Circulation 2021;143:1673-86.

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: Blood Pressure, Cardiology Interventions, Cardiomyopathies, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diuretics, Glomerular Filtration Rate, Heart Failure, Hemodynamics, Hemoglobins, Natriuretic Peptide, Brain, Pulmonary Artery, Secondary Prevention, Stroke Volume


< Back to Listings