A clinical research study assessing the effects of an investigational medicine when compared with placebo for people with heart failure
The heart works by pumping the blood that carries and delivers oxygen around your body. “Heart failure” means your heart isn't pumping blood as well as it should, therefore you might feel shortness of breath, are unable to perform daily activities, and other symptoms caused by the fact that you’re not getting enough oxygen. The primary goals of heart failure care are to prevent the disease worsening and the improvement of symptoms. The GARDEN study will compare the effects of an investigational medicine with a placebo when given to people with heart failure.
Who may participate
Joining a clinical trial is an important and personal decision. By volunteering in clinical research, you can make a difference. Thank you for considering the GARDEN study.
The GARDEN study is enrolling approximately 416 people aged 18 years old or older who have heart failure and fatigue, unintentional weight loss, or muscle weakness.
If you think this study may be right for you, you’ll review the details with the study team and ask any questions you may have. If you choose to participate, you will sign the informed consent document and continue with screening, to confirm whether you meet all the eligibility criteria and are able to participate. The screening period will last up to 8 weeks.
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
Participants will be assigned by chance (like pulling a number out of a hat) to one of two treatment groups.
One group (54% of participants) will receive the investigational medicine and the other group (46% of participants) will receive the placebo. The placebo looks like the study medicine but does not contain any active ingredients.
This study is ‘double-blind’, which means neither you nor the study team will know which study group you have been assigned.
The study medicine and placebo are both administered as a subcutaneous (under the skin) injection using a small needle inserted into your arm, leg or abdomen. All participants will receive 2 injections of the placebo during their second screening visit to assess how they respond to injection.
Frequently Asked Questions
Is taking part in this clinical trial voluntary?
Yes, participation in clinical trials is completely voluntary: taking part in a trial is your choice. You are free to stop being in this trial at any time and for any reason and it will not affect your future medical care in any way.
Why do we need clinical trials?
Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical research studies also help us learn more about the side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.
Are there any risks?
There are some risks associated with taking any medication, and the investigational study medicine is no different. It is possible your condition or health may improve, worsen, or stay the same. If your health gets worse, the study team and the study doctor will help you decide what to do, which may mean stopping your participation in the study.
Participant safety is the top priority of this clinical trial. Before you participate, you will be provided with an informed consent document that explains the potential risks and benefits in detail. Your health will also be monitored by the study team while in the study.
Are there any benefits?
Participation may help people in the future by increasing our understanding of the investigational medicine and heart failure, but there may be no direct benefit to you.
What is Informed Consent?
Informed consent is one of the most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the trial.
During informed consent, you will be given all details about the study, including potential benefits and risks of taking part.