Phase 3
N=72
A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03332212 ↗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
| Outcome | Result | p-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
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.