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: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-12
• 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 at signing of informed consent
History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days before randomization)
LVEF = 35%, per subject's most recent medical record, within 12 months prior to screening. The most recent qualifying LVEF must be at least 30 days after any of the following, if applicable: 1) an event likely to decrease EF
(eg, myocardial infarction, sepsis); 2) an intervention likely to increase EF (eg, cardiac resynchronization therapy, coronary revascularization); or 3) the first ever presentation for HF.
NYHA class II to IV at most recent screening assessment
Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
Oral SoC therapies for chronic HF (eg, beta blockers, renin-angiotensinaldosterone system inhibitors) should be present, if not contraindicated. Subjects enrolled during either HF hospitalization or early after HF hospitalization discharge can be reinitiating or titrating oral SoC chronic HF therapies at the same time of randomization with the goal of achieving optimized therapy on study.

Currently hospitalized with primary reason of HF OR one of the following events within 1 year to screening: 1) hospitalization with primary reason
of HF; 2) urgent visit to ED with primary reason of HF
B-type natriuretic peptide (BNP) level = 125 pg/mL or an NT-proBNP
level = 400 pg/mL at most recent screening assessment (subjects
receiving angiotensin receptor-neprilysin inhibitor [ARNi] must use NT-proBNP assessment; for subjects in atrial fibrillation/flutter at screening, 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

Factors expected to interfere with the subject's availability or ability to
complete all protocol-required study visits or procedures, and/or to
comply with
all required study procedures to the best of the subject and
investigator's knowledge (including ongoing substance abuse).

Inability to swallow study medication tablet (eg, swallowing disorders,
feeding tubes)

Receiving mechanical hemodynamic support (eg, intra-aortic balloon
pump counterpulsation), or invasive mechanical ventilation = 7 days
prior to randomization

Receiving IV inotropes (eg, dobutamine, milrinone, levosimendan) or IV
vasopressors (eg, epinephrine, norepinephrine, dopamine, or
vasopressin)
= 3 days prior to randomization

Receiving IV diuretics or IV vasodilators, supplemental oxygen therapy,
or non-invasive mechanical ventilation (eg, bilevel positive airway
pressure
[BiPAP] or continuous positive airway pressure [CPAP] = 12 hours prior
to randomization (Note: the use of non-invasive ventilation for sleep
disordered breathing is permitted)

Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-
elevation myocardial infarction, unstable angina), stroke, or transient
ischemic attack, major cardiac surgery or cardiac intervention (ie,
implantation of cardiac closure devices, cardiac resynchronization
therapy, or catheter ablation), percutaneous coronary intervention, or
valvuloplasty/other cardiac valve repair or implantation within the 3
months prior to randomization

Insertion of other cardiac devices (eg, implantable cardioverter
defibrillator, permanent pacemaker, monitoring devices) within 30 days
prior to randomization

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

Study & Design

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