A clinical trial assessing the potential benefits of a study medicine 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 enough blood to meet the body’s needs. You might feel shortness of breath along with other symptoms, and you may struggle to perform daily activities. The primary goal of heart failure care is to prevent the disease from worsening and to improve your symptoms.
The GARDEN trial will assess the potential benefits of an investigational medicine when given to people with heart failure. Participants will receive care from a team of dedicated healthcare professionals throughout the trial.
Who may participate
Joining a clinical trial is an important and personal decision. By volunteering for clinical research, you can make a difference. Thank you for considering the GARDEN trial.
We are enrolling approximately 416 people aged 18 years old or older who have heart failure with fatigue, unintentional weight loss, or muscle weakness.
Many factors, including genetics, race, ethnicity, and sex, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
Condition
Heart failure and fatigue
Age
18+ years
Sex
Male or Female
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 to one of two treatment groups.
Group 1, (54% of participants) will receive the study medicine and the other group (46% of participants) will receive the placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
This study is ‘double-blind’, meaning neither the participant nor the study team will know whether the participant is receiving the study medicine or the placebo.
Both the study medicine and the placebo are administered as a shot.
Length of study treatment
Up to 32 weeks
Number of study visits
About 11
Long-term follow up
10 weeks after last dose
Frequently Asked Questions
The study medicine is thought to work by targeting a particular protein in the body called GDF-15 (growth differentiation factor-15), which, at increased levels, may be responsible for some of the underlying symptoms of heart failure, including fatigue, loss of appetite, weight loss, and impaired mobility.
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.
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.
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.
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.
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.
