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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (9 UK sites)
Harefield Hospital
Harefield UB96JH, United Kingdom
Southampton General Hospital
Southampton SO166YD, United Kingdom
Queen Elizabeth University Hospital
Glasgow G514TF, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke RG249NA, United Kingdom
Castle Hill Hospital
Cottingham HU165JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Russells Hall Hospital
Dudley DY12HQ, United Kingdom
Ulster Hospital
Dundonald BT161RH, United Kingdom
Glasgow Royal Infirmary
Glasgow G40SF, United Kingdom
Great Western Hospitals
Swindon SN36BB, United Kingdom
How to Get in Touch
Cytokinetics MD
Sponsor contactCONTACT
