Frequently Asked Questions
About COMET-HF
What are the benefits?
Being in the COMET-HF study may not directly help participants. Participating in the study may benefit other people in the future by helping us learn more about heart failure and possible treatments for HFrEF.
What are the possible risks?
In a similar study, participants reported these side effects while taking omecamtiv mecarbil:
- dizziness
- chest pain
Because omecamtiv mecarbil is still being studied, there may be side effects that we do not know about at this time. Potential participants will be given more information about possible side effects during screening to help them decide if they want to enroll or not.
Will participants have to go to a study clinic?
Yes, participants will have several visits throughout the study to check their overall health and heart condition.
- During Screening: Potential participants will have an in-person visit at the study clinic to talk with the study doctor about their current medicines and health conditions to make sure the study is a good fit for them.
- During Year 1: Participants will have at least 5 in-person visits and 2 remote visits by video or phone call.
- After Year 1: Participants will switch every 12 weeks between remote and in-person visits until the end of the study.
- At the End of the Study: Participants will have a remote visit to check how they are doing 4 weeks after their last dose of the study medicine.
What can participants expect during study visits?
The study doctors will give potential participants details about the study visits and tests during the screening period. Health tests during study visits may include:
- Electrocardiograms, also called ECGs or EKGs
- physical exams
- vital sign measurements
- blood draws
- questions about the participant’s health and daily activities
Will it cost anything to participate?
No – there is no cost to participate in this study and no cost for you if you take part. The study medicine (omecamtiv mecarbil or placebo) will be provided to you at no cost. Study tests and visits not part of a participant’s standard of care will be covered by the study sponsor. “Standard of care” is the care a participant would receive whether or not they are part of the clinical trial.
Will participants receive reimbursement?
Yes – participants will receive reimbursement for their travel costs and meals. The study team will provide details about reimbursement when they review the study activities with potential participants.
Will the study cover travel costs?
Yes – participants may be eligible for reimbursement to cover the cost of traveling to study visits. Participants should talk with their study team about covering travel costs.
Can participants leave the study after they start?
Yes – participants may withdraw their consent and leave the clinical trial at any time.
About Clinical Trials
A clinical trial is a research study that helps to answer important questions about a study medicine. Clinical trials help researchers learn if the study medicine has any beneficial effects in treating a certain condition and what the potential side effects are. All medications must be evaluated in a clinical trial before they can be approved and prescribed to patients.
Every clinical trial follows a protocol (plan) that describes everything about the study, like how often participants need to visit a study clinic and what health checks will take place. These plans are reviewed by ethics committees or institutional review boards made up of special groups of people—including doctors, scientists, lawyers, and community members—whose job is to protect the safety of participants.
Clinical trials are needed to answer research questions and to help researchers learn if a certain study medicine works better or is safer than not taking anything at all. Some questions researchers may want to answer in a clinical trial are “What are the benefits of the study medicine?” and “What are the possible side effects?”
Participating in a clinical trial is a voluntary opportunity. It is always up to the potential participant to decide if they want to take part in a research study or not. People participate in clinical trials for a variety of reasons, such as:
- They want to try a new medicine because their health has not improved after using the currently approved medicine(s).
- They want to try a new medicine even if it may not be better or as good as medicine that is already available.
- They want to help with the development of a new treatment for other people with the same or a similar disease.
A placebo looks like the study medicine but does not have any active ingredients. Participants who take a placebo are important to the study. They help the study team learn if taking the study medicine works better or is safer than not taking anything at all.
No – participants, their study doctors, and the study teams will not know which group participants are in. This is to protect the study results from being influenced by anyone. If a participant has a health emergency, their doctors can find out if they are taking the active study medicine or the placebo.
All study staff will follow local, national, and regional privacy laws for protected health information (PHI) and personal identifiable information (PII). Study staff will store participants’ information in a safe place.
In the United States, the Privacy Rule and HIPAA (Health Insurance Portability and Accountability Act) protect health information. Residents of some US states – like California, Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Tennessee, Texas, Utah, and Virginia – may have state-specific PII privacy rights.
To view Cytokinetics’ Privacy Policy, please visit cytokinetics.com/privacy-policy or contact [email protected].
Omecamtiv mecarbil is an investigational drug, which means it has not been approved by any regulatory agency. Its safety and effectiveness have not been established.
Interested in participating in COMET-HF?
This study will enroll participants in the United States, Canada, and Europe.
Details about enrollment requirements and contact information for study sites are provided in the study record on clinicaltrials.gov (NCT06736574). Sites are added to the study record as they begin enrolling participants.
People who want to learn more about the COMET-HF study may email [email protected].