A study investigating the use of Omecamtiv Mecarbil on subjects with heart failure

Phase 1

• Conditions: Chronic Heart Failure With Reduced Ejection Fraction; MedDRA version: 19.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002299-28-GR
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8285

Inclusion Criteria

Subject has provided informed consent

Male or female, = 18 to = 85 years of age

History of chronic HF

LVEF = 35%

NYHA class II to IV

Managed with HF SoC therapies consistent with regional clinical practice guidelines

Current hospitalization with primary reason of HF or prior HF hospitalization, or urgent HF admission to emergency department (ED) within 1 year prior to screening

BNP level = 125 pg/mL or an NT-proBNP level = 400 pg/mL at most recent screening assessment (for subjects with atrial fibrillation, the cut off levels are: BNP = 375 pg/mL or NT proBNP = 1200 pg/mL)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7457
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 828

Exclusion Criteria

Inability to swallow study medication tablet

Receiving mechanical hemodynamic support or mechanical ventilation = 7 days prior to randomization

Receiving IV inotropes or IV vasopressors = 3 days prior to randomization

Receiving IV diuretics or IV vasodilators, or supplemental oxygen therapy = 12 hours prior to randomization
Acute coronary syndrome, stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 3 months prior to randomization

Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease

Routinely scheduled outpatient intravenous infusions for HF (eg, inotropes, vasodilators, diuretics) or routinely scheduled ultrafiltration

Systolic blood pressure > 140 mmHg or < 85 mmHg, or diastolic blood pressure > 90 mmHg, or heart rate > 110 beats per minute, or < 50 beats per minute at screening

Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified