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This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.

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ClinicalTrials.gov Identifier: NCT03448406
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF > 40%).

Secondary objectives are to assess Patient-Reported Outcome (PRO)


Condition or disease Intervention/treatment Phase
Heart Failure Drug: Empagliflozin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Preserved Ejection Fraction (HFpEF) (EMPERIAL - Preserved)
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Empagliflozin Drug: Empagliflozin
Film-coated tablet
Other Name: JARDIANCE, JARDIANZ, GIBTULIO

Active Comparator: Placebo Drug: Placebo
Film-coated tablet




Primary Outcome Measures :
  1. the change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions [ Time Frame: Week 0 and Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline to week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS) [ Time Frame: Week 0 and Week 12 ]
  2. Change from baseline to week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized format (CHQ-SAS) dyspnea score [ Time Frame: Week 0 and Week 12 ]
  3. Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes [ Time Frame: Week 0 and Week 6 ]
  4. Change from baseline in Clinical Congestion Score at week 12 [ Time Frame: Week 0 and Week 12 ]
  5. Change from baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at week 12 [ Time Frame: Week 0 and Week 12 ]
  6. Change from baseline in Patient Global Impression of Dyspnea Severity at week 12 [ Time Frame: Week 0 and Week 12 ]
  7. Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at week 12 [ Time Frame: Week 12 ]
  8. Patient Global Impression of Change in Dyspnea at week 12 [ Time Frame: Week 12 ]
  9. Change from baseline in N-terminal pro-brain natriuretic peptide (NTproBNP) at week 12 [ Time Frame: Week 0 and Week 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
  • Male or female patients. Women of child bearing 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 ICHGCP and local legislation prior to admission to the trial
  • Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
  • Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
  • Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
  • Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1
  • Patients must have at least one of the following evidence of heart failure (HF):

    • Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
    • Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
  • Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control symptoms, patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1 to control symptoms.
  • Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).

Exclusion Criteria:

  • Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischemic attack in past 90 days prior to Visit 1
  • Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
  • Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
  • Type 1 Diabetes Mellitus (T1DM)
  • Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
  • Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2
  • SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
  • Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 1 (Screening)
  • Unstable angina pectoris in past 30 days prior to Visit 1
  • Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
  • Any presence of condition that precludes exercise testing such as:

    • claudication,
    • uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
    • significant musculoskeletal disease,
    • primary pulmonary hypertension,
    • severe obesity (body mass index ≥40.0 kg/m2),
    • orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
    • amputation with artificial limb without stable prosthesis function for the past 3 months
    • Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
  • Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
  • ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
  • Implanted cardiac resynchronisation therapy (CRT)
  • Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
  • Further exclusion criteria applies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448406


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03448406     History of Changes
Other Study ID Numbers: 1245-0167
2017-004072-59 ( EudraCT Number )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs