Frequently Asked Questions
About AMBER HFpEF
What are my responsibilities in the clinical trial?
Trial participants who participate in the clinical trial will be responsible for visiting their clinical trial site for screening, trial treatment visits, and follow-up appointments. During the clinical trial period, trial participants will be required to visit their clinical trial site for up to 7 clinic visits over the entire study duration. You will be asked to provide blood samples (blood) and undergo procedures that might be different from a regular medical examination. This study will involve physical examinations, vital sign measurements, and tests to see how your heart is working. Any additional responsibilities and clinical trial information will be explained by the clinical trial physician
Your participation will involve up to 7 visits to the research site and the study will be about 14 weeks in duration, not including the Screening visit. Over the entire study, you’ll have:
- Echocardiograms
- Electrocardiograms (ECGs)
- Exercise Echocardiography Tests
- Blood draws
- Questionnaires about your health
You will also have the option to participate in the following:
- Optional Genetic sub-study: blood sample collected as part of a study visit blood draw to determine whether participants’ genes, which are responsible for many of the body’s functions and traits, impact the way that CK-4021586 may impact the body
- Optional Pharmacokinetics Sub-study: additional blood samples collected at the Week 2 study visit to measure the amount of study drug metabolites in your blood at various times
Can I leave the clinical trial after I start?
Yes, you may withdraw consent and choose to no longer participate in the clinical trial at any time.
Does this clinical trial offer travel reimbursement?
Yes, trial participants may qualify for reimbursement related to clinical trial visits. Trial participants should let their clinical trial physician know if they require assistance.
How do I get started?
Please visit https://clinicaltrials.gov/study/NCT06793371 for more information about this clinical trial, as well as a listing of all clinical trial sites. In addition, you may contact [email protected] or 650-624-2929 for more information.
Participation in a clinical trial is an important decision that should be properly considered between the trial volunteer, the treating physician, and the clinical trial site investigator. There are many factors the physician and clinical trial site investigator will take into consideration to determine if participating in a clinical trial is appropriate.
About Clinical Trials
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these include studying whether an investigational drug has any beneficial effects in treating a certain condition and what the potential side effects are. All medications must be tested in a clinical research study before they can be approved and prescribed to patients.
Clinical trials are conducted to answer research questions and to help researchers learn if a certain investigational drug is safe and effective. The main questions the researchers want to answer are:
What are the Benefits?
Being in this study may not help you directly. But your participation in the study may benefit other people in the future by helping us learn more about your medical condition and develop drugs to help other patients with HFpEF.
What are the Possible Side Effects?
You may have side effects while in this study. Researchers do not know all the side effects that could happen.
Participating in a clinical trial is a voluntary opportunity, and thus, it is always up to the individual interested in participating to decide if they would like to do so. People participate in clinical trials for different reasons, some of which may be:
- They have not experienced improvement of the condition after using the currently approved drug(s)
- They want access to a new type of drug even if it is not guaranteed to be better or as good as already available drugs
- They want to contribute to the development of a new drug for others with a similar disease
A placebo is a substance designed to look like the investigational drug but contains no active ingredient. Clinical trials will use a placebo to test the safety and effectiveness of an investigational drug. Researchers learn from comparing results of the placebo to the actual investigational drug.
Participating in a clinical trial involves collection of certain information about you, with your full consent. Medical information privacy is covered by the Privacy Rule and HIPAA; certain other personally identifiable information that you may provide may be covered by state privacy laws.
If you are a resident of certain states, like California (or Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Tennessee, Texas, Utah, and Virginia), you may have certain privacy rights about your personally identifiable information. To view Cytokinetics’ Privacy Policy, please visit cytokinetics.com/privacy-policy/ or contact [email protected].
CK-4021586 is an investigational drug and is not currently approved for use by regulatory agencies like the FDA – its safety and effectiveness have not been established.