Omecamtiv Mecarbil for Heart Failure
(COMET-HF Trial)
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Cytokinetics
Must be taking: Loop diuretics
Must not be taking: Digoxin
Disqualifiers: Acute coronary syndrome, Dialysis, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking digoxin and have atrial fibrillation. You must also be on standard heart failure treatments for at least 30 days before joining the study.
What data supports the effectiveness of the drug Omecamtiv Mecarbil for heart failure?
Research shows that Omecamtiv Mecarbil helps improve heart function and reduces the risk of worsening heart failure or death in patients with heart failure and reduced ejection fraction. It is particularly beneficial for patients with low blood pressure who often struggle with other treatments.12345
What makes the drug Omecamtiv Mecarbil unique for treating heart failure?
Omecamtiv Mecarbil is unique because it is a cardiac myosin activator, which means it helps the heart muscle contract more effectively, potentially improving heart function in heart failure patients. This mechanism of action is different from other heart failure treatments that typically focus on reducing the workload of the heart or managing symptoms.678910
Research Team
CM
Cytokinetics MD
Principal Investigator
Cytokinetics
Eligibility Criteria
This trial is for people with chronic heart failure who have a severely reduced ejection fraction, which means their hearts are not pumping blood well. Participants should meet specific health criteria but the provided details on eligibility are incomplete.Inclusion Criteria
* 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
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either omecamtiv mecarbil or placebo twice daily until at least 850 participants experience a HF event or CV death
Up to 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Omecamtiv Mecarbil (Cardiac Myosin Activator)
Trial OverviewThe study is testing Omecamtiv Mecarbil (OM), an experimental drug, to see if it can help reduce complications from heart failure like hospital stays, needing a transplant, or risk of death. Some participants will receive OM while others will get a placebo for comparison.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omecamtiv MecarbilExperimental Treatment1 Intervention
Participants randomized to omecamtiv mecarbil will be dosed based on their omecamtiv mecarbil plasma concentration at 25, 37.5 or 50 mg twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Capital Area Research, LLCCamp Hill, PA
Broward Research CenterMiami Beach, FL
Reid Physician AssociatesRichmond, IN
Advanced Cardiovascular, LLCAlexander City, AL
More Trial Locations
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Who Is Running the Clinical Trial?
Cytokinetics
Lead Sponsor
Trials
44
Patients Recruited
17,500+
Findings from Research
In the GALACTIC-HF study involving 8232 patients, omecamtiv mecarbil significantly reduced the risk of cardiovascular death or heart failure events in patients with low systolic blood pressure (SBP ≤100 mmHg), showing a hazard ratio of 0.81, indicating a strong efficacy in this high-risk group.
Importantly, omecamtiv mecarbil did not affect SBP levels over time and was well tolerated, meaning it did not increase the risk of adverse events compared to placebo, making it a safe option for patients with heart failure and low blood pressure.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effects of omecamtiv mecarbil in heart failure with reduced ejection fraction according to blood pressure: the GALACTIC-HF trial.Metra, M., Pagnesi, M., Claggett, BL., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Population Pharmacokinetic Properties of Omecamtiv Mecarbil in Healthy Subjects and Patients With Heart Failure With Reduced Ejection Fraction.Chen, PW., Trivedi, A., Lee, E., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Omecamtiv Mecarbil in Black Patients With Heart Failure and Reduced Ejection Fraction: Insights From GALACTIC-HF.Lanfear, DE., Njoroge, JN., Adams, KF., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety and efficacy of omecamtiv mecarbil for heart failure: A systematic review and meta-analysis.Alqatati, F., Elbahnasawy, M., Bugazia, S., et al.[2022]
In the GALACTIC-HF trial involving 8232 patients, omecamtiv mecarbil significantly reduced the risk of worsening heart failure events and cardiovascular death, showing similar efficacy in both hospitalized and outpatient settings.
Hospitalized patients had a higher rate of worsening heart failure events compared to outpatients, but omecamtiv mecarbil was effective in lowering this risk regardless of whether treatment was initiated during hospitalization or as an outpatient.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Effect of Omecamtiv Mecarbil in Hospitalized Patients as Compared With Outpatients With HFrEF: An Analysis of GALACTIC-HF.Docherty, KF., McMurray, JJV., Diaz, R., et al.[2023]
In a study involving 20 healthy subjects, the bioavailability of omecamtiv mecarbil (OM) was assessed using two novel minitablet formulations, showing that the slow-release minitablets had similar bioavailability to the adult matrix formulation, indicating they could be effective for pediatric use.
The fast-release minitablets demonstrated even higher bioavailability compared to the adult formulation, with no serious adverse events reported, suggesting a favorable safety profile for these new formulations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Relative Bioavailability of Omecamtiv Mecarbil Pediatric Minitablet Formulations in Healthy Adult Subjects.Trivedi, A., Mackowski, M., Jafarinasabian, P., et al.[2021]
Omacetaxine mepesuccinate demonstrated significant efficacy in chronic myeloid leukemia (CML) patients who were resistant or intolerant to two or more tyrosine kinase inhibitors, achieving a major cytogenetic response in 20% of patients, with some responses lasting over 17 months.
The treatment was generally well-tolerated, with the most common severe side effects being hematologic issues like thrombocytopenia (67%) and neutropenia (47%), indicating that while there are risks, the benefits in terms of response rates are clinically meaningful.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Subcutaneous omacetaxine mepesuccinate in patients with chronic-phase chronic myeloid leukemia previously treated with 2 or more tyrosine kinase inhibitors including imatinib.Cortes, JE., Nicolini, FE., Wetzler, M., et al.[2021]
In a real-life study of 118 patients with acute myeloid leukemia (AML) in France, venetoclax combined with hypomethylating agents or low-dose cytarabine showed promising efficacy, with overall response rates of 51.9% and 41.2%, respectively.
The median progression-free survival was 4.0 months for venetoclax with hypomethylating agents and 3.4 months with low-dose cytarabine, indicating that while effective, treatment complexity necessitates harmonization of practices across treatment centers.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Retrospective, real-life study of venetoclax plus azacitidine or low-dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy.Laloi, L., Billotey, NC., Dumas, PY., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Venetoclax in combination with hypomethylating agent for the treatment of advanced myeloproliferative neoplasms and acute myeloid leukemia with extramedullary disease.Sanber, K., Ye, K., Tsai, HL., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Real-world experience of venetoclax with azacitidine for untreated patients with acute myeloid leukemia.Winters, AC., Gutman, JA., Purev, E., et al.[2020]
References
Effects of omecamtiv mecarbil in heart failure with reduced ejection fraction according to blood pressure: the GALACTIC-HF trial. [2023]
Population Pharmacokinetic Properties of Omecamtiv Mecarbil in Healthy Subjects and Patients With Heart Failure With Reduced Ejection Fraction. [2022]
Omecamtiv Mecarbil in Black Patients With Heart Failure and Reduced Ejection Fraction: Insights From GALACTIC-HF. [2023]
Safety and efficacy of omecamtiv mecarbil for heart failure: A systematic review and meta-analysis. [2022]
The Effect of Omecamtiv Mecarbil in Hospitalized Patients as Compared With Outpatients With HFrEF: An Analysis of GALACTIC-HF. [2023]
Relative Bioavailability of Omecamtiv Mecarbil Pediatric Minitablet Formulations in Healthy Adult Subjects. [2021]
Subcutaneous omacetaxine mepesuccinate in patients with chronic-phase chronic myeloid leukemia previously treated with 2 or more tyrosine kinase inhibitors including imatinib. [2021]
Retrospective, real-life study of venetoclax plus azacitidine or low-dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy. [2023]
Venetoclax in combination with hypomethylating agent for the treatment of advanced myeloproliferative neoplasms and acute myeloid leukemia with extramedullary disease. [2023]
Real-world experience of venetoclax with azacitidine for untreated patients with acute myeloid leukemia. [2020]