Heart Failure Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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 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

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 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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT03875183

Recruitment Status:

Recruiting

Sponsor:

Innolife Co., Ltd.

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There are 12 Locations for this study

See Locations Near You

UCLA School of Medicine
Torrance California, 90502, United States
Innovative Research of West Florida, Inc.
Clearwater Florida, 33756, United States
Universal Axon Clinical Research
Doral Florida, 33166, United States
Grady Clinical Research Center
Atlanta Georgia, 30303, United States
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita Kansas, 67214, United States
Clinical Trials of America LA, LLC
Monroe Louisiana, 71203, United States
St Louis Heart and Vascular
Saint Louis Missouri, 63136, United States
Clinical Research of Gastonia
Gastonia North Carolina, 28054, United States
Medication Management, LLC
Greensboro North Carolina, 27401, United States
Stern Cardiovascular
Germantown Tennessee, 38138, United States
East Texas Cardiology
Houston Texas, 77002, United States
Angiocardiac Care of Texas
Houston Texas, 77025, United States
Chongqing University 3 Gorges Hospital
Chongqing , , China More Info
Lirong Qui
Contact
15523798618

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT03875183

Recruitment Status:

Recruiting

Sponsor:


Innolife Co., Ltd.

How clear is this clinincal trial information?

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