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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Empagliflozin Impact on Hemodynamics in Patients With Heart Failure

NCT03030222

Heart Failure

COMPLETED PHASE4

EMPA Acute Heart Failure

NCT03554200

Diabetes Mellitus, Type 2 Acute Heart Failure

TERMINATED PHASE2

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

NCT03057951

Heart Failure

COMPLETED PHASE3

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

NCT03057977

Heart Failure

COMPLETED PHASE3

Empagliflozin for Peripheral Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

NCT06046612

Heart Failure With Preserved Ejection Fraction Microvascular Dysfunction

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A (Empagliflozin + Placebo)

Heart Failure with Reduced Ejection Fraction

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

12 weeks

Placebo

Intervention Type DRUG

12 Weeks

Cohort B (Empagliflozin + Placebo)

Heart Failure with Preserved Ejection Fraction

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

12 weeks

Placebo

Intervention Type DRUG

12 Weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin

12 weeks

Intervention Type DRUG

Placebo

12 Weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

JARDIANCE, JARDIANZ, GIBTULIO JARDIANCE, JARDIANZ, GIBTULIO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 3 months prior to informed consent in patients without ICD
* Diagnosis of cardiomyopathy induced by chemotherapy or peripartum within the 12 months prior to informed consent
* Symptomatic bradycardia or second or third degree heart block in need of a pacemaker after adjusting beta-blocker therapy or any other negative inotropic agents, if appropriate
* Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalisation for exacerbation within 12 months prior to informed consent, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
* Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT),or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening
* Impaired renal function, defined as estimated Creatinine Clearance \< 30 mL/min (using Cockcroft-Gault formula) or requiring dialysis, as determined at screening
* Haemoglobin \< 10 g/dL at screening
* Type 1 Diabetes Mellitus (T1DM)
* History of ketoacidosis
* Major surgery (major according to the investigator's assessment) performed within 3 months prior to informed consent, or scheduled major elective surgery (e.g. hip replacement) within 3 months after Visit 1
* Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator's opinion
* Any documented active or suspected malignancy or history of malignancy within 6 months prior to informed consent, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix or low risk prostate cancer (patients with pretreatment PSA \<10 ng/mL, and biopsy Gleason score of ≤ 6 and clinical stage T1c or T2a)
* Presence of any other disease than heart failure with a life expectancy of \<1 year in the investigator's opinion
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
* Patients with requirement for treatment with empagliflozin according to local standard of care
* Treatment with any SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor within 1 week prior to informed consent or during screening period until Visit 2 (Randomisation)
* Currently enrolled in another investigational device or drug study, or less than 30 days between randomisation and ending another investigational device or drug study, or receiving other investigational treatment(s). Patients participating in a purely observational trial will not be excluded.
* Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
* Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
* Women who are pregnant, breastfeeding, or who plan to become pregnant while in the trial
* Any clinical condition that would jeopardise patients safety while participating in this trial, or may prevent the subject from adhering to the trial protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No