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Trial to evaluate safety of the combined use of oral BI 690517 and empagliflozin for HF and LVEF

UCI Specialty Area: Cardiology
Principal Investigator: Dawn Lombardo
Official Title: A Phase III double-blind, randomized, parallel-group superiority trial to evaluate efficacy and safety of the combined used of oral BI 690517 and empagliflozin compared with placebo and empagliflozin in patients with heart failure (HF) (New York Heart Association [NYHA] classes II to IV) and left ventricular ejection fraction (LVEF) greater than or equal to 40%
A Study On:
Heart - Cardiovascular Circulatory
Heart Failure

Study Description

Eligibility

Inclusion criteria:

  1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
  2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (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 and instructions on the duration of their use is provided in the participant information
  4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before Visit 2
  5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
  6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:

a. in participants with body mass index (BMI) less than 27 kg/m²: greater than or equal to 300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and greater than or equal to 900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)

b. in participants with BMI greater than or equal to 27 kg/m² to less than 35 kg/m²: greater than or equal to 220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and greater than or equal to 660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)

c. in participants with BMI greater than or equal to 35 kg/m²: greater than or equal to 125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and greater than or equal to 375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)

  1. At least one of the following:

a. Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1

b. Documented hospitalisation for HF within 6 months prior to Visit 1

c. Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1

  • in participants without Afib or Aflutter (at Visit 1 ECG): greater than or equal to 900 pg/mL
  • for participants with Afib or Aflutter (at Visit 1 ECG): greater than or equal to 1800 pg/mL
  1. Participants must be treated according to best possible standard of care (SOC) in accordance with applicable HF local/international guidelines (according to the judgment of the investigator)

Exclusion criteria:

  1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
  2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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