AppremedPrivacy Policy Upright HTM
Scientific summary of the study in lay language
High blood pressure (hypertension) and diabetes are undoubtedly important risk factors for kidney disease and cardiovascular disease. Guidelines recommend monitoring of the self-measured blood pressure at home (HTM) to diagnose hypertension and treat high blood pressure with great accuracy. Furthermore, proteins are the building blocks and motors of all organs in the human body. Small proteins and their breakdown products pass through the kidney filter and end up in the urine. Modern technology allows more than 5,000 of such protein fragments to be measured in a single urine sample of two millilitres. In medical jargon, the totality of these 5000 proteins and their breakdown products is known as the urinary proteome (UPP). Measurement of the UPP allows understanding disease processes long before they give rise to complaints.
The study for which you were invited has the abbreviated name UPRIGHT-HTM. The aim of this study is to investigate the extent to which HTM and UPP contribute to estimating the risk, to which patients may be exposed, even at a time when there are no complaints. UPRIGHT-HTM focuses on a decline in renal function, loss of the pumping function of the heart or on complications related to the kidneys or cardiovascular system. More than 1,000 patients will be recruited in Europe, sub-Saharan Africa, the United States and South America and randomly assigned to an investigational group and a control group. All patients will receive a device, which will allow them to measure their blood pressure at home regularly – if possible, daily. These measurements will be exported to a study website. In all patients, the UPP will be measured once on a 2-milliliter urine sample at the start of the study. All patients and their caregivers will have access to the HTM data via the internet during the whole 4-year follow-up. Patients from the investigational group and their caregivers will be informed on the UPP results shortly after the start of the study. The patients assigned to the control group and their caregivers will receive this information at the end of the study. This design should allow to determine whether knowledge of the UPP is indeed contributing to a more accurate diagnosis and treatment of the health risk. Health care providers will inform all patients how to adapt their lifestyle to reduce their risk. Health care providers will follow existing guidelines to treat risk factors, such as high blood pressure, diabetes or disturbed blood fat levels. UPRIGHT-HTM is not a study of new or existing drugs. All pills, which will be prescribed to control risk factors, are recommended in official treatment guidelines and have a high safety profile. If with your participation UPRIGHT-HTM achieves its objective, the study results will help to improve the care of many other patients with a risk profile similar to yours.
Conduct of the study
Your care provider (general practitioner, specialist or nurse) invited you to participate in the UPRIGHT-HTM study, as you currently you do not have any symptoms related to a reduced function of your kidneys or heart. However, your doctor has observed that you are at risk of developing a reduction in the function of these organs over the next few years, a condition that can evolve over the longer term into kidney or heart failure or other complications cardiovascular-renal complications.
UPRIGHT-HTM is a study comparing two diagnostic instruments that allow your health care provider to set up your treatment, namely, the self-measurement of blood pressure at home and a urinary marker, which can be determined on a small urine sample of 2 millilitres. Several studies have proven that patients, who measure their blood pressure at home, on average, have a 5 mm Hg lower systolic blood pressure (also known as "high pressure"; blood pressure during the contraction of the heart muscle), compared to patients who do not follow their blood pressure at home. Your doctor will provide you with a home blood pressure measurement device free of charge and ask you to measure your blood pressure regularly – if possible, once daily. You will be asked to take the home blood pressure readings after five minutes of rest in the sitting position in the morning before breakfast and before taking medicines. You and your doctor can access these blood pressure readings at any time via the internet.
At the start of the study, you will also be asked to deliver a 2 milliliter urine sample in a vial, which your doctor will make available to you. After collecting the urine sample, please, close the vial properly. You can store this urine sample in the freezer compartment of your refrigerator for a few days or in a deep freezer. Your doctor will be responsible for shipping your urine sample for a free determination of the urinary markers, which in previous studies predicted health problems at the level of the kidneys, heart and blood vessels, but require further validations. In 50% of patients, you and your doctor will have access to the urinary marker results shortly after the test and in 50% of patients at the end of the 4-year study period. This design makes it possible to check whether the urinary marker has an added value in personalising your treatment over and beyong the home blood pressure measurements. To check complaints and to know your quality of life, your doctor will ask you to complete a questionnaire at the beginning and end of the study and at 6‑month intervals during the study. Via an internet link you can complete these questioonaires at home, but your doctor can also help you with this, if necessary. Your doctor will remain completely free to organise your follow-up to her/his insights, to carry out diagnostic tests, and to prescribe the medicines necessary to treat your risk factors – all within the framework of your health insurance and in compliance with the current guidelines. The study team will process your data without knowing your identity. You will be identified by a unique study number. Only your doctor has access to your personal information. At the start of your participation in the study, your doctor will ask you to sign a consent form, which will be kept in her/his medical files.
You can leave the study at any time, although your doctor and the research team hope that you will complete the planned 4-year study period, as this allows setting up your treatment with the utmost accuracy, thereby protectiong the function of your kidneys and heart. If you leave the study early, your doctor will pass on your home blood pressure measurement device to another patient. Afterwards, your doctor will continue to treat you, but only with knowledge of your home blood pressure readings and the urinary marker until the moment you left the study.
Additional information
The only procedures added in UPRIGHT-HTM to routine care are home blood pressure measurement and the single 2‑millilitre urine collection. There are no risks involved. The urine sample will be destroyed after analysis.
Medical Ethics Committee
UPRIGHT-HTM was evaluated favourably by the ethics committee of the University Hospitals Leuven. The task of an ethics committee is to protect participants in clinical trials. It checks whether your rights as a patient and as a participant in a study are fully respected, whether the balance between risks and benefits is beneficial, and whether the study is scientifically relevant and ethically sound. On this issue, the ethics committee of the University Hospitals Leuven concluded that UPRIGHT-HTM complies with the Belgian law of 7 May 2004. You should in no way regard the positive opinion of an ethics committee as an encouragement to participate in this a study.
Voluntary participation
Do not hesitate to ask any questions that might come to your mind before you sign. Take time to talk about your participation with any thrustworthy person, if you wish. You have to decline participation or to stop your particpation at any time without having to give a reason, even if you have previously agreed to be enrolled in UPRIGHT-HTM. Your decision will in no way affect your relationship with your doctor/caregiver nor have a negative influence on the quality of your further care. If you accept to participate in UPRIGHT-HTM, sign the consent form. The doctor/caregiver will also sign this form and will confirm that she/he has given you all necessary information about this study. You will receive a copy of the consent form. For your safety, it is recommended to inform ypur doctor/caregiver should you decide to stop your participation in the study. This information will enable you doctor/caregiver ensuring the continuation of your treatment in the best possible way after you left the UPRIGHT-HTM study.
Costs associated with your participation
If you decide to participate in UPRIGHT-HTM, this will not entail any additional costs for you or health insurer. Only routinely charged costs related to the regular medical care of your condition within the context of your healh insurance will be charged to your insurer and to you for what is not covered by the health insurance.
Confidentiality - Privacy Policy
Your participation in the study impliers that you agree that your doctor/caregiver collects data about you and that these data can be used in a research context, for instance for scientific presentations and medical publications. Your data will be processed in accordance with the European General Data Protection Regulation (GDPR) and the Belgian Legislation on the Protection of Privacy. Prof JA Staessen is responsible for the confidential usage of your data. You have the right to ask your doctor/caregiver what data she/he has collected and what they are used for in the context of the UPRIGHT-HTM. These data include information on your current medical condition, your medical history, and the results of tests/examinations that were performed to assess your health status according to the current standard of care. You have the right to review these data and to have them corrected, if needed.
The study team is obliged to treat the collected data confidentially. This means that your doctor/caregiver will never disclose your name or data that might disclose your identity, for example in the context of a publication or conference. Your doctor/caregiver will only share encrypted data, i.e., your identity will be replaced by an identification code in the study. Your doctor/caregiver will be the only person who can make a link between shared study data and your medical record during the entire clinical trial and beyond.
Encrypted research data can be shared with Belgian and other national/international regulatory authorities, to relevant ethics committees, to other doctors and/or institutions that have a collaboration with the sponsor in the contexct of UPRIGHT-HTM.
If you have questions about how your data will be used, you can always contact your doctor/caregiver. The data protection officer of the ethics committee of the University Hospitals Leuven is also at your disposal (DPO-UZ Leuven, Herestraat 49, 3000 Leuven, Belgium; e-mail dpo@uzleuven.be). Finally, if you have a complaint about the processing of your data, you can contact the Belgian supervisory authority, which monitors compliance with the basic principles of the protection of personal data. The Belgian supervisory authority is called the Data Protection Authority (GBA), Drukpersstraat 35, 1000 Brussels (telephone, +32 2 274 48 00; email: contact@apd-gba.be; website: www.gegevensbeschermingsautoriteit.be).
Upright HTM app
Here we explain how we collect, use, disclose, and safeguard your information when you use our mobile application Upright-HTM ("the App").
The Upright HTM app ("The App") has two functions:
- it wirelessly collects data from a blood pressure monitor using Bluetooth technology
- it can redirect you to the trial platform to fill out questionnaires
In the app settings you will need to enter the activation code you will be given and the serial number of the blood pressure device. There is no other data the app collects.
To be able to connect wirelessly to the blood pressure monitor, the app will need to have access to the phone's location data.
The location data are not used, stored, collected or transfered in any way, other than what is necessary to connect and communicate with the blood pressure device.
The app wil require that you allow access to location data to be able to connect with the blood pressure monitor.
Access to storage is needed to store the results from the blood pressure device.
The App will ask permission to these services when you use the app. Declining permission will result in not being able to correctly use the app.
We use administrative, technical, and physical security measures to help protect your personal information. The security of the physical device the app is installed on (the smartphone) is the responsibility of the owner of the device.
The app is not intended for children under 13 years of age.