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Looking for participantsPhase3

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

Sponsor: Cytokinetics

NCT ID: NCT06736574

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Omecamtiv Mecarbil (OM) (drug), Placebo (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Omecamtiv Mecarbil (OM) — drug: Oral Tablet · Placebo — drug: Oral Tablet
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called omecamtiv mecarbil (also known as CK-1827452) for adults with long-term chronic heart failure where the heart pumps very little blood (severely reduced ejection fraction). The study is paid for (sponsored) by a company called Cytokinetics. It aims to include people who have recently had a heart failure event or a worsening of symptoms needing more water tablets (diuretics).

Who can take part

  • Adults aged 18 to 85
  • Have had chronic heart failure needing treatment for at least 3 months before joining
  • Take water tablets called loop diuretics regularly
  • For people without atrial fibrillation (an irregular heart rhythm) on their heart trace (ECG): the heart's pumping strength (left ventricular ejection fraction) is below 30%, and a heart stress blood test (NT-proBNP or BNP) is raised
  • For people with atrial fibrillation on their ECG: the heart's pumping strength is below 25%, the heart stress blood test is higher, and they are not taking digoxin
  • Have had a recent heart failure event, for example: being in hospital mainly for heart failure, a heart failure event in the past 12 months, or needing a big increase in water tablets or a new type of water tablet for at least a week
  • Have been on standard heart failure treatments for at least 30 days before joining
  • Have a top blood pressure number (systolic) of 140 mmHg or lower

Who may not be able to

  • Have atrial fibrillation on the ECG and are taking digoxin
  • Have had a heart event or procedure in the last 3 months that could change the heart's pumping strength, such as a heart attack, heart bypass or valve surgery, or certain device therapies
  • Live in a long-term care facility or hospice
  • Are expected to live less than 12 months for reasons not related to the heart, based on the doctor's judgement
  • Are on drip (intravenous) heart-strengthening medicines or blood pressure-supporting medicines within 3 days before joining
  • Are on mechanical heart support or a breathing machine within 7 days before joining
  • Are on drip water tablets, drip blood vessel relaxants, or extra oxygen within 12 hours before joining (night-time oxygen for sleep apnoea or heart failure is allowed)
  • Have very poor kidney function (eGFR below 20) or are on dialysis
  • Have had a solid organ transplant
  • Are taking part in another study drug or device study, or were in one within the past 30 days
  • Have taken omecamtiv mecarbil in an earlier study
  • Are pregnant, planning pregnancy, or planning to breastfeed during the study or within 5 days after treatment ends
  • Have certain specific heart muscle problems, such as cardiac amyloidosis, or severe narrowing of a heart valve

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Visit and study duration details are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 85 Years
Who
All
Number of participants
1,800
Started
2024-12-19
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase3 - 1,800 participants
  • • The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction

Who can take part?

  • • Ages 18 Years to 85 Years
  • • Diagnosed with heart failure

Where?

  • • Harefield - Harefield Hospital
  • • Southampton - Southampton General Hospital
  • • Glasgow - Queen Elizabeth University Hospital
  • • Basingstoke - Basingstoke and North Hampshire Hospital
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

More detail

This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF). Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed. Estimated duration of participation: Up to 3 years.

Heart FailureHeart Failure With Reduced Ejection Fraction

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 85 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Adult patients who meet all the following criteria at screening may be included in the study:
  • ✓Are between ≥ 18 years and ≤ 85 years at the signing of agreement to take part
  • ✓Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening
  • ✓Are receiving oral loop diuretics on a regular schedule
  • ✓Patients without AFF on screening ECG:

Who cannot take part

  • ✗Any of the following criteria will exclude potential patients from the study:
  • ✗Have AFF on the screening ECG and are currently taking digoxin
  • ✗Are admitted to a long-term care facility or hospice
  • ✗Have a projected survival of \< 12 months due to non-cardiovascular causes based on clinical judgment
  • ✗Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening
See the full criteria
Inclusion Criteria: Adult patients who meet all the following criteria at screening may be included in the study: * Are between ≥ 18 years and ≤ 85 years at the signing of informed consent * Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening * Are receiving oral loop diuretics on a regular schedule * Patients without AFF on screening ECG: * LVEF \< 30% within 6 months of screening * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL) * Patients with AFF on screening ECG: * LVEF \< 25% within 6 months of screening * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL) * Not currently taking digoxin * Meet one of the following criteria for a recent HF event: * Are currently hospitalized with the primary reason of HF * Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or * Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic. * Are established on regional standard-of-care HF therapies for at least 30 days prior to screening * Systolic blood pressure ≤ 140 mmHg Exclusion Criteria: Any of the following criteria will exclude potential patients from the study: * Have AFF on the screening ECG and are currently taking digoxin * Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening * Are admitted to a long-term care facility or hospice * Have a projected survival of \< 12 months due to non-cardiovascular causes based on clinical judgment * Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening * Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening * Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure) * Have an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 or receiving dialysis at screening * Have previously had a solid organ transplant * Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening * Have received omecamtiv mecarbil in a previous clinical trial * Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP * Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease

Where Is This Study? (9 UK sites)

Harefield Hospital

Harefield UB96JH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Southampton General Hospital

Southampton SO166YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Queen Elizabeth University Hospital

Glasgow G514TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Basingstoke and North Hampshire Hospital

Basingstoke RG249NA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Manager

research.team@hhft.nhs.uk01256 473202 Ext 4557

Castle Hill Hospital

Cottingham HU165JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Russells Hall Hospital

Dudley DY12HQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Claire Phillips

dgft.research.rhh@nhs.net01384 456111

Ulster Hospital

Dundonald BT161RH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephanie Kelly

Research.Development@setrust.hscni.net02895980075

Glasgow Royal Infirmary

Glasgow G40SF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Great Western Hospitals

Swindon SN36BB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

How to Get in Touch

Cytokinetics MD

Sponsor contact

CONTACT

(650) 624-2929 medicalaffairs@cytokinetics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07