We are conducting the BRANCH-HF (heart failure) clinical trial to evaluate whether a trial medicine can reduce symptoms and prevent worsening of the disease in people with heart failure.
Heart failure has a profound impact on people who experience it. The disease often worsens over time, even with existing treatments, and most patients become hospitalized in the course of their disease.
More treatment options with better efficacy and fewer side effects are needed.
If you participate in this clinical trial, you will receive care from a team of dedicated specialists, while contributing to research that could benefit many other people with heart failure in the future.
Who may participate
Joining a clinical trial is an important and personal decision. We thank you for considering participation as an option that may be right for you.
The BRANCH-HF trial is enrolling people 18 years of age and older who:
- Have been diagnosed with heart failure for at least 3 months
- Have not experienced a heart attack in the last 3 months
- Have not been hospitalized for heart disease in the last 30 days
There will be other requirements which the trial team will discuss with you.
Condition
Heart failure
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
The clinical trial will last for up to 48 weeks, and you will typically have 10 clinic visits and 5 telephone calls in total.
The treatment period will last for around 36 weeks, and you will take the trial medicine as a tablet once daily.
You will have about a 7 out of 10 chance of receiving the trial medicine. You will have about a 3 out of 10 chance of receiving a placebo. A placebo does not have any medicine in it, but it looks just like the trial medicine being studied.
Length of study treatment
About 48 weeks
Number of study visits
Typically 14-15
About heart failure
Heart failure occurs when heart muscles are weakened, and the heart is unable to pump enough blood to meet the body’s needs. This can be caused by a variety of underlying conditions such as heart disease, high blood pressure, and disease of the heart muscle itself caused by genetic or environmental factors.
Heart failure often worsens over time, even with existing treatments, and most patients become hospitalized in the course of their disease. This research study will evaluate whether the trial medicine can reduce symptoms and prevent worsening of the disease in people with heart failure.
The importance of representation
It’s important that all people with heart failure have treatment options that work for them. Ensuring diversity within clinical trials enables us to see how a trial medicine works in different types of people. We’ll be looking at factors like age, sex, and ethnicity to see if the treatment is effective for all people with heart failure.
Frequently asked questions
Heart failure occurs when heart muscles are weakened, and the heart is unable to pump enough blood to meet the body’s needs. This can be caused by a variety of underlying conditions such as heart disease, high blood pressure, and disease of the heart muscle itself caused by genetic or environmental factors.
Heart failure may worsen over time, even with existing treatments, and many patients become hospitalized in the course of their disease.
The trial medicine is thought to work by improving the breakdown of branched-chain amino acids (BCAAs) that can be elevated in people with heart failure. BCAAs are an essential nutrient found in protein rich foods such as meat, dairy and pulses. Although necessary for muscle growth and repair, BCAAs are often found in higher levels in people with heart failure. It is hoped that by improving the breakdown of these substances in the body, the trial medicine may reduce their negative effects on the heart.
You will be assigned by chance (like picking numbers out of a hat) to receive either the trial medicine or a placebo.
In this clinical trial, you will have about a 7 out of 10 chance of receiving the trial medicine. You will have about a 3 out of 10 chance of receiving a placebo. A placebo does not have any medicine in it, but it looks just like the trial medicine being studied.
Randomly assigning treatments and using placebos are necessary to confirm the results of a clinical trial.
Heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure, is a type of heart failure which happens when the heart is able to pump out a normal amount of blood but struggles to fill back up with blood.
People with this type of heart failure will be included in the BRANCH-HF clinical trial.
Heart failure with moderately reduced ejection fraction (HFmrEF), is a type of heart failure which happens when the heart’s ability to pump blood is slightly reduced, and it also struggles to fill back up with blood.
People with this type of heart failure will be included in the BRANCH-HF clinical trial.
