Clinical Research Directory

Heart and Blood Vessels Health in People With Cystic Fibrosis

Cystic fibrosis (CF) is a disease that affects over 11,000 people in the UK. It is a genetic condition that affects many organs including the lungs, pancreas, kidneys and liver. New drugs called "modulators" have meant people with CF are now living much longer. Until recently, heart disease was rare in CF, but with the new modulators there are increasing concerns that heart disease may become a big problem in the future. This is partly to do with the drugs causing weight gain and higher blood pressure, which are risk factors for heart disease. My PhD project aims to find out whether the blood vessels and hearts of people with CF are healthy or diseased. I will then find out how the blood vessels are changing over time and work out what things are driving those changes. I will measure the health of the blood vessels and heart using an ultrasound machine to understand what the pattern of disease is like and who might be at the highest risk for heart disease in the future. I will then repeat these measurements a year later. I will compare people of different ages and with different types of disease to understand what things may help us identify heart disease as soon as possible. In the general population, doctors often use medical prediction tools to find out who is at the highest risk for heart disease. We do not know if these work for people with CF, so I will also find out whether those prediction tools are useful in CF. It is vital to understand who may be at risk for heart disease, as one of the most effective ways of treating heart disease is to prevent it from happening. This work may pave the way for future studies to test early treatment for heart disease in those people we identify might be at high risk. Early prevention treatment could reduce the risk of heart disease and ultimately improve the length and quality of life of people living with CF. This is particularly important given people with CF already have a much shorter life expectancy than the general population. In summary, this PhD project will help improve our understanding of heart disease in CF and help identify the best way forward to prevent heart disease causing health problems related to heart disease for these individuals in the future.

Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity

What is the purpose of this research? This research aims to compare three different methods of measuring pulse wave velocity, which is the main parameter used for assessing arterial stiffness. This parameter is as important as blood pressure in predicting future cardiovascular risk. The investigators intend to compare carotid-femoral pulse wave velocity, which is the gold standard for measuring arterial stiffness, with brachial pulse wave velocity measured using a device similar to a blood pressure monitor and a mathematical formula validated in a large European population. Who is eligible for this survey? Anyone aged 18 or older who has been invited may participate, provided they sign an informed consent form. Where will the field research be conducted? The research will be conducted at a health center specializing in the treatment of hypertension. This center is a reference for outpatient blood pressure monitoring in the city of Uberaba (MG), Brazil. Patients enrolled in the study will also be included in the Hypertension Center of the Faculdade de Medicina de São José do Rio Preto (FAMERP). Which procedures will be performed by research participants? All participants who consent will answer some questions about their demographic and health information. A trained nurse will measure their weight, height, and blood pressure after a 5-minute rest, and then measure carotid-femoral pulse wave velocity. The participant will lie down on a bed and the nurse will place a sensor on the middle of their neck and the groin. The device will automatically deliver the parameters. At least three measurements are required for each participant. Measurements normally take between 10 and 15 minutes. Then, participants will wear a device to record blood pressure and pulse wave velocity for 24 hours. The nurse will fit the cuff around the participant's arm and attach the monitoring device to a belt around their waist. The device will take measurements every 20 to 30 minutes. 24 hours later, the participant must return to the research venue to have the equipment removed. What are the risks and adverse events of the procedures? There are no known risks or adverse events (AEs) associated with carotid-femoral pulse wave velocity measurements. The risks of this research are minimal, limited to discomfort during the AMBP recording, which occurs at a low frequency. However, excessive arm pain, allergic reactions, and edema may occur. To minimize these risks, a nurse will be available via telephone to aid all participants during the AMBP recordings.