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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Reduced Ejection Fraction

In brief

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).

Key facts

Study ID

NCT03875183

Run by

Innolife Co., Ltd.

People needed

200

Starts

2020-01-20

Expected to finish

2023-01-01

Last updated by the study team

2022-03-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 screening for patients without atrial fibrillation or atrial flutter, or, NT-proBNP ≥ 1,200 pg/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

You may not qualify if…

• 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 study participation will potentially pose a major risk to patient's safety and well-being
• Need for routine scheduled outpatient IV infusions for Heart Failure or scheduled ultrafiltration
• 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

Where it is running

• Chongqing University 3 Gorges Hospital — Chongqing, China (enrolling)
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Universal Axon Clinical Research — Doral, Florida, United States
• Grady Clinical Research Center — Atlanta, Georgia, United States
• Via Christi Research, a division of Via Christi Hospitals Wichita, Inc. — Wichita, Kansas, United States
• Clinical Trials of America LA, LLC — Monroe, Louisiana, United States
• UCLA School of Medicine — Torrance, California, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• Medication Management, LLC — Greensboro, North Carolina, United States
• Stern Cardiovascular — Germantown, Tennessee, United States
• East Texas Cardiology — Houston, Texas, United States
• Angiocardiac Care of Texas — Houston, Texas, United States
• St Louis Heart and Vascular — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.