What is the PINNACLE clinical research study?
If you live with POTS, please know that you are not alone in your medical journey. People with POTS experience an abnormally large increase in heart rate when they start standing up. This may lead to symptoms of lightheadedness, blurred vision, and shortness of breath, amongst others. Because of these symptoms, people with POTS may feel that performing normal activities in daily life is difficult.
Currently, we are working on developing a potential treatment for POTS. PINNACLE is a clinical research study that aims to see if an investigational treatment is safe, well-tolerated, and effective in people with POTS.
Am I eligible?
What are the study treatments?
Investigational treatment: The investigational treatment targets a cell protein called natriuretic peptide receptor 1 (NPR1), which is found on the surface of different types of cells in the body. Blocking the activity of the NPR1 is expected to increase blood volume and/or blood pressure, and remove the trigger for an elevated heart rate. This treatment is not approved by any public health agency for any condition.
Placebo: A placebo looks like a treatment but does not contain any real medicine. Researchers can tell whether an investigational treatment is effective by understanding if it works better than a placebo.
Once the study doctor confirms that you qualify, you will be randomly assigned to 1 of 3 arms, each consisting of about 27 participants. You will have a 67% (2 out of 3) chance of being assigned to an arm that will receive the investigational treatment and a 33% (1 out of 3) chance of being assigned to an arm that will only receive placebo.
What can I expect if I participate?
Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the PINNACLE study. You may leave the study at any time without it affecting your regular health care.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures. For example, you will be asked to lie down, sit, or stand up while your blood pressure is being measured with a blood pressure cuff around one of your arms. Other procedures include drawing some of your blood (by having a needle in your arm), recording the activity of your heart with an electrocardiogram (ECG), and in between some study visits you may have to wear a wearable cardiac monitor (WCM), a small device placed on your chest that records your heart’s activity. Your participation may last up to about 18 weeks with about 8 on-site study visits.
Qualified participants may be reimbursed for food costs and for travel to and from study visits, and medical care related to their participation, including the study treatment, will be provided at no cost. The study team will discuss all of this with you.
How can I take part?
If you wish to take part in the PINNACLE study, you can fill in a short pre-screener questionnaire to see if you may be eligible
Am I eligible?
What else should I know?
As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatments may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.
Please note that this clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities and which has not received marketing authorization in any country.
Find a study site near you
To find out more about the PINNACLE study, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.
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