Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

Last updated: March 28, 2022
Sponsor: Innolife Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT03875183
INL1-001
2019-000511-89
  • Ages 18-75
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of HF requiring chronic treatment of loop diuretics
  • Left Ventricular Ejection Fraction (LVEF) ≤ 40% at screening by echocardiography
  • N-Terminal-prohormone of Brain Natriuretic Peptide (NT-proBNP) ≥400 pg/mL at screeningfor patients without atrial fibrillation or atrial flutter, or, NT-proBNP ≥ 1,200pg/mL at screening for patients with atrial fibrillation or atrial flutter
  • Treated for Heart Failure with stable, optimal pharmacological therapy
  • Acceptable screening echocardiographic image quality

Exclusion

Exclusion Criteria:

  • Female patients of childbearing potential
  • Patients with a New York Heart Association (NYHA) Class I or IV
  • Heart failure that is clearly caused by toxin / drug such as Adriamycin
  • Significant medical conditions or recent history suggesting the patient's studyparticipation will potentially pose a major risk to patient's safety and well-being
  • Need for routine scheduled outpatient IV infusions for Heart Failure or scheduledultrafiltration
  • History of rhabdomyolysis or history of autoimmune diseases
  • Severe renal disease
  • Hepatic disease
  • Pulmonary disease limiting exercise capacity
  • Atrial fibrillation with rapid ventricular response
  • Life expectancy of less than 6 months
  • Type 1 diabetes mellitus or Type 2 diabetes mellitus with very poor glycemic control
  • Patients with anemia

Study Design

Total Participants: 200
Study Start date:
January 20, 2020
Estimated Completion Date:
January 31, 2023

Connect with a study center

  • Chongqing University 3 Gorges Hospital

    Chongqing,
    China

    Active - Recruiting

  • UCLA School of Medicine

    Torrance, California 90502
    United States

    Site Not Available

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Completed

  • Universal Axon Clinical Research

    Doral, Florida 33166
    United States

    Site Not Available

  • Cardiovascular Research Center of South Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • Grady Clinical Research Center

    Atlanta, Georgia 30303
    United States

    Completed

  • IACT Health

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Our Lady of the Lake Hospital, Inc.

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Clinical Trials of America LA, LLC

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • St Louis Heart and Vascular

    Saint Louis, Missouri 63136
    United States

    Completed

  • Duke University School of Medicine

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Clinical Research of Gastonia

    Gastonia, North Carolina 28054
    United States

    Completed

  • Medication Management, LLC

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Stern Cardiovascular

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Angiocardiac Care of Texas

    Houston, Texas 77025
    United States

    Completed

  • East Texas Cardiology

    Houston, Texas 77002
    United States

    Completed

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