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Phase 3 N=72 Randomized Double-blind Treatment

A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin

Heart Failure

Enrolled (actual)
72
Serious AEs
11.3%
Results posted
Jun 2021
Primary outcome: Primary: Change From Baseline to Week 12 in PCr/ATP Ratio in the Resting State Measured by 31P Cardiac Magnetic Resonance Spectroscopy (MRS). — 0.068; 0.259; -0.179; 0.100 PCr / ATP Ratio — p=0.1418

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Empagliflozin (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boehringer Ingelheim
Primary completion
May 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to Week 12 in PCr/ATP Ratio in the Resting State Measured by 31P Cardiac Magnetic Resonance Spectroscopy (MRS).
0.068; 0.259; -0.179; 0.100 0.1418

Summary

The objective of this trial is to assess the effect of empagliflozin on cardiac physiology and metabolism aiming to provide a scientific explanation of the underlying mechanism by which empagliflozin improves HF related outcomes in patients with chronic heart failure

Eligibility Criteria

Inclusion Criteria

  • Chronic heart failure diagnosed at least 3 months before informed consent
  • NYHA class II-IV at screening
  • Age ≥ 18 years at screening
  • Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Cohort A Heart Failure with Reduced Ejection Fraction (HFrEF)

  • Left ventricular ejection fraction (LVEF) ≤ 40% as measured by ECHO at screening
  • The following signs of heart failure;
  • Elevated NT-proBNP (>125 pg/mL) at screening in patient without atrial fibrillation (AF)
  • Elevated NT-proBNP (>600 pg/mL) at screening in patient with AF
  • Appropriate dose of medical therapy for HF (such as ACEi, ARB, β-blocker, oral diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international HF guidelines, stable for at least one week prior to Visit 1 and during screening period until Visit 2 (Randomisation) with the exception of diuretics which must be stable for at least one week prior to Visit 2 to control symptoms. If required, the investigator must document in the source documents the reason why the patient is not on the target dose per local guidelines.

Cohort B Heart Failure with Preserved Ejection Fraction (HFpEF)

  • Left ventricular ejection fraction (LVEF) ≥ 50% as measured by ECHO at screening and no previous measurement of LVEF ≤ 40%.
  • The following combined signs of heart failure;
  • Structural heart disease (LA enlargement [LAVI >34 mL/m2] and/or LVH [LVMI ≥ 115 g/m2 for males and ≥ 95 g/m2 for females]) by ECHO at screening or within 3 months prior to informed consent AND
  • NT-proBNP > 125pg/mL at screening in patient without AF or NT-pro-BNP > 600 pg/mL in patient with AF
  • Oral diuretics, if prescribed, should be stable for at least one week prior to Visit 1 and during screening period until Visit 2 (Randomisation).

Exclusion Criteria

  • Stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
  • Any patients with myocardial scars and/or non-viable myocardium in the interventricular septum, unstable angina due to significant coronary artery disease (CAD), or major (in the opinion of the investigator) cardiovascular surgery.
  • Any contraindication for MRI, CPET and/or dobutamine stress test in accordance with the institution guidance, including implanted left ventricular assist device (LVAD),implantable cardioverter defibrillator (ICD), cardiac resynchronisation therapy (CRT) or any cardiac device.
  • Heart transplant recipient or listed for heart transplant
  • Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
  • Moderate to severe uncorrected valvular heart disease, obstructive or regurgitant, or any valvular heart disease expected to lead to surgery in the Investigator's opinion
  • Acute decompensated HF (exacerbation of chronic HF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or LVAD or hospitalisation within 1 week prior to Visit 1 (Screening), or during screening period until Visit 2 (Randomisation)
  • Systolic blood pressure (SBP) ≥ 180 mmHg at screening. If SBP >150 mmHg and <180mmHg at screening, the patient is ineligible if receiving 3 or more antihypertensive drugs
  • Symptomatic hypotension and/or a SBP < 100 mmHg at Screening
  • Atrial fibrillation which is uncontrolled in the opinion of the investigator
  • Untreated ventricular arrhythmia with syncope documented within the
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03332212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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