Extract

Background and study aims Chronic heart failure (HF) is a leading cause of death and disability, despite great advances in medical, interventional and device therapies. Patients suffering from heart failure often have raised levels of a substance in their blood known as Galectin-3. Studies have shown that Galectin-3 controls the production of a protein in the body called collagen. Collagen is known to accumulate within tissues, causing cirrhosis and fibrosis (the collection of fibrous deposits), which if severe enough can cause scarring and damage to some of the body’s organs, including the heart. This damage could, if severe enough, lead to the heart not functioning properly. Reducing the levels of Galectin-3 in the body could therefore have an important role in improving the health of patients suffering from heart failure. The harmful effects of Galectin-3 can be blocked by Modified Citrus Pectin (MCP). MCP is available to buy from a variety of retailers (health shops and supermarkets) and is made from the peel and pulp of citrus fruits, such as oranges. The aim of our study is to test if MCP could be helpful as an additional treatment for patients with chronic HF. In order to prove this we need to carry out a study to compare MCP with a placebo (dummy) tablet. Who can participate? You should be at least 18 years old, have a clinical diagnosis of heart failure, be attending the Hull and East Yorkshire Hospitals NHS Trust’s heart failure service, and have high levels of galectin-3 in your blood (we will do a blood test to find this out). What does the study involve? If you are suitable to enter the study following a screening visit, you will be given a prescription to take either MCP or a matched placebo for 18 weeks. Which capsule you take will be decided randomly – like tossing a coin. After that period you will take the other capsule for another 18 weeks. It means you will take both the active and placebo in turn during your time in the study. This way, we directly compare the effect of the active capsule and the placebo on your health. During the study, we will use echocardiography to take ultrasound pictures of your heart to look for any physical changes – such as structural changes and how efficiently the heart pumps. We will also take some blood samples to look at certain biomarkers (natural substances in your blood associated with the severity of heart failure) and to see if Galectin-3 levels are reduced by the capsules. Some of the blood samples will be analysed by our research partners in Scotland. These samples will be coded so that they cannot be traced to you. We will give you some dietary sheets to fill out each day. What are the possible benefits and risks of participating? It is not known whether taking MCP has any direct benefits to your health. This is the purpose of the study, and as such you should assume that there are no direct benefits to you in participating in this study. We hope that the results of this study will help others in the future. MCP contains fibre which may cause transient minor stomach upset, including wind, but has no lasting side-effects. MCP may raise levels of a substance in the body called potassium. We will provide advice about how best to prepare your meals to help with this and we will regularly measure levels of potassium in your blood so that this does not become a problem for you. Providing a blood sample can cause bruising and soreness. Where is the study run from? The study is run from the Castle Hill Hospital in Cottingham, East Yorkshire. When is the study starting and how long is it expected to run for? The study will start in 2015 and will run for 2 years. Who is funding the study? We are applying for funding from the British Heart Foundation (UK). Who is the main contact? Kenneth Wong [email protected]

Inclusion criteria

• Heart failure

Links

• ictrp
• isrctn