Two types of MR scans will be performed: MR Spectroscopy: this scan measures fat in the heart and the liver and determines the energy levels of your heart at rest and dobutamine infusion (a medication that mimics exercise). This medication mimics the level of exercise similar to daily activities such as walking up stairs.
MRI: Following the spectroscopy scans you will have an MRI scan to assess cardiac function. This is the traditional MR scan which is used routinely in clinical practice for assessing the structure and function of your heart. You will need to lie very still on your back as movement can blur the images. We will ask you to breathe in and out and hold your breath for several seconds for some of the scans. You will be given medication (called Adenosine ) through a cannula in your arm. It is used routinely in MR scans in hospitals. The Adenosine stimulates the heart and will make you feel like you are exercising. This allows us to measure the blood supply to your heart. You will then be given a contrast dye (called gadolinium) through a
cannula in your arm. The dye makes the images of your heart and blood flow more visible and is used routinely in MR scans in hospitals. This dye will also allow for assessment of any scarring in the heart.
Before the scan, we will take blood samples to be analysed as part of the research. It should be possible to take this at the same time as the cannula is put in your arm before the MRI scan, meaning no extra needles will be involved. With your permission, we will store some of these samples and analyze them at the end of the study for heart markers; some other samples such as diabetes control tests will be analyzed immediately.
Dapagliflozin
Dapagliflozin is a well-established diabetes medication. It is taken as a pill once a day. You will be given instructions on how to take it safely and the study team will be available to support you throughout the study.
Dapagliflozin is considered safe; however, it may have side effects. These can include increased urination, thirst, urinary tract infections, or a small risk of genital infections. Your blood sugar, kidney function, and overall health will be monitored with blood and urine tests before and during the study to ensure your safety.
Contraceptive protection
If you are female and have childbearing potential, you must use a medically-approved, highly effective birth control method while on the study to prevent pregnancy. Acceptable methods of contraception include:
- Barrier-type devices (e.g., female condom, diaphragm, and contraceptive sponge) used only in combination with a spermicide;
- Intrauterine devices (IUDs);
- Oral contraceptive agents started at least 90 days before enrolling in the study;
- Depo-Provera (medroxyprogesterone acetate) shot;
- Levonorgestrel implants;
- Naturally or surgically sterile (amenorrheic for at least 1 year and no record of childbirth for naturally sterile persons); or
- Male partner is sterile and is the only sexual partner.
True or periodic abstinence, the rhythm method or contraception by the male partner only are not acceptable methods. If you are male with a female partner of childbearing potential, you do not have to use any birth control methods.
Expenses
We will reimburse travel and parking expenses for study visits (receipts are required). We will offer you light lunch and refreshments for each of the research visits. We are also happy to arrange transport to the hospital and return you home if needs be.
What are the possible disadvantages and risks of taking part?
MR scanning is used routinely in clinical practice to acquire images of various body parts. MR scans are safe, non-invasive and do not involve any ionizing radiation (x-rays). Some people find the space limitation in the scanner uncomfortable, but you will be given a chance to see the scanner to make sure that you are comfortable in it before the study starts. The whole time that you are in the scanner you will be given a buzzer that you will be able to use at any time if you wish to stop the study. The radiographer will go through a list of possible risks with you before you go into the scanner.
MR scans are painless but involve the use of a strong magnetic field, so if you have any of the following, you would not be suitable for a scan, and would not be able to take part in this study:
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permanent pacemaker or defibrillator |
metal clips in blood vessels of the brain |
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injury to the eye involving fragments of metal |
shrapnel injuries |
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other metal or electronic implants |
If you are a woman who is pregnant, breast-feeding or who may become pregnant during the study period, you will not be able to take part.
If you feel claustrophobic, you can request that the scan be stopped. Unfortunately, if the scan is stopped for this reason, because the health information this study investigates can only be obtained through MR scans, you will be unable to continue to participate in the study.
The scan requires a gadolinium based contrast injection. This is the safest contrast agent used in medical practice with a very low risk of serious side effects (1 in 10 000). Because
there was a historical concern that poor kidney function may in rare cases increase side effects with gadolinium, any subject with end-stage kidney disease will not be able to participate in this study.
In the unlikely event of us seeing any abnormalities on your MR scan, a member of our research team will discuss the implications with you and, with your permission, your GP may be notified. However, it is important to note that we do not carry out scans for diagnostic purposes, and therefore these scans are not a substitute for a clinical appointment. Rather, our scans are intended for research purposes only.
The department is equipped to cope with allergic reactions if they happen. Adenosin, the medication we use to increase the blood flow to the heart, can cause flushing, breathlessness and chest discomfort. However, all of these feelings usually subside within one or two minutes or even more quickly when the medication is stopped.
Some people find having a drip in their arm uncomfortable and there can be bruising at the site of needle entry. Our staff are highly trained in drip insertion and we will make sure you are as comfortable as possible.
What are the possible benefits of taking part?
There are no direct benefits to you if you take part in this study. This study does not form part of your normal clinical care and is done solely for research purposes. It may be interesting to see moving images of your own heart and learn more about your heart function, and body organ fat content.
What happens when the research study stops?
You will officially end participation in the study when you have completed visit 2. Copies of any publications connected to this study will be available on request from Prof Svein Plein (S.plein@leeds.ac.uk). Study drugs will be provided by Gp, if patients have the indication to have it. We will make recommendations to your GP;
What if there is a problem?
The University has arrangements in place to provide for negligent harm arising from participation in the study for which the University is the Research Sponsor. NHS indemnity operates in respect of the clinical treatment with which you are provided. If you wish to complain about the way you have been dealt with during the study or any possible harm you might have suffered, please contact Prof Sven Plein or the Leeds Teaching Hospitals NHS Trust Patient Advice and Liaison Service (PALS). Contact details can be found in Part 2.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in confidence.
please read the additional information in Part 2 before making any decisions.
Part 2
What will happen if I don’t want to carry on with the study?
You are free to withdraw at any time, without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect you in any way. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. Any stored blood or urine samples that can still be identified as yours will be destroyed if you wish.
Will my taking part be kept confidential?
All information collected about you during the course of the study will be kept strictly confidential. This information will be securely stored, electronically on the Leeds General Infirmary secure server, and on paper, under the provisions of the 2018 Data Protection Act. The data collected will be coded and your personal details will be kept separately. You will not be identified in any publication that may result from this research. We will retain your personal details for 15 years after the end of the study according to local archiving policy. At the end of these 15 years, your personal details will be destroyed. If we keep any of your plasma samples, these will be stored in -80°C freezers in an access-controlled, secure environment, in the Leeds Teaching Hospitals NHS Trust Research laboratories and University of Leeds laboratories. Only authorised staff have access to these laboratories. Plasma from blood samples will be stored for up to 3 years for future research after the study has ended. Urine samples will be destroyed after testing is completed. We will discuss your individual results with you after your tests.
With your permission, we will inform your GP of your participation in the study. If any unexpected abnormality or condition were found, we would inform your GP with your permission.
With your permission, your anonymised data may also provide a resource for future studies. If any information from this study is used to develop new research, data protection regulations will be observed and strict confidentiality maintained. Any information about you which leaves the hospital will have your name and address removed so that you cannot be identified. Your data and/ or images may be sent to institutions in the UK, the European Economic Area (EEA) or outside the EEA. Ethical approval will be obtained for any future studies involving your data. If you withdraw consent from further study follow-up, or if you were to become incapacitated, any data collected about you up to that point will remain on file and will be included in the final study analysis.
The University of Leeds is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The University of Leeds will keep and store identifiable information about you for 15 years after the study has finished. This information will also be held by Leeds Teaching Hospitals NHS Trust. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. You can find out more about how we use your information by contacting the University Data Protection Officer at DPO@leeds.ac.uk. You can also find the University of Leeds’ Privacy Notice for Research Participants here: https://dataprotection.leeds.ac.uk/wp-content/uploads/sites/48/2019/02/Research-Privacy-Notice.pdf. You can also see the Health Research Authority’s Patient Leaflet here: https://dataprotection.leeds.ac.uk/wp-content/uploads/sites/48/2019/09/HRA-transparency-wording.pdf
Leeds Teaching Hospitals NHS Trust and the University of Leeds will use your name, NHS number, and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the University of Leeds and regulatory organizations may look at your medical and research records to check the accuracy of the research study. The Leeds Teaching Hospitals NHS Trust will pass these details to the University of Leeds along with the information collected from you and/or your medical records. The only people in the University of Leeds who will have access to information that identifies you will be people who need to contact you to confirm information or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
What will happen to the results of the research study?
When the study is complete the results will be published in a medical journal, but no individual patients will be identified. If you would like a copy of the published results, please ask your doctor.
Abnormal & Incidental Findings
It is unlikely that the scan will detect clinically significant cardiac abnormalities. However, should this occur, with your permission your GP will be informed in writing and they will be able to arrange further investigation and treatment if necessary. It is possible the finding of significant cardiac abnormalities could have an impact on your insurance. You may not be informed of subtle abnormalities that are not deemed to be of clinical relevance.
Indemnity/Compensation
The University has arrangements in place to provide for negligent harm arising from participation in the study for which the University is the Research Sponsor. NHS indemnity operates in respect of the clinical treatment with which you are provided. If you are harmed as a direct result of taking part in this study, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds to a legal action. Regardless of this, if you have any cause to complain about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms are available to you.
The research organization
This is a research project of the Cardiac MRI department of the Leeds General Infirmary and the University of Leeds. This study is funded ………………………………
Who has reviewed the study?
The study has been reviewed and ……………………… It is also approved both by a nationally approved Research Ethics Committee and your hospital’s Research and Innovation Office. More details can be provided, on request, by your study doctor.
What if there are any problems?
If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should Contact Prof Sven Plein, email (S.Plein@leeds.ac.uk). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. The Leeds Teaching Hospitals NHS Trust Patient Advice and Liaison Service can be contacted on 0113 2066261 or patientexperience.leedsth@nhs.net.
Will l be informed of the results of the study?
On completion of the study, you will be given written feedback with the results and if you would like any further information we would be happy to discuss this with you.
Questions
If you have any further questions about the study, or would like to be included in this research, please call Prof Sven Plein on 0113 3438023 or write to Prof Plein, the Cardiology Department, Jubilee Wing, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX.
You can also contact the Research Nurses here:
- Research Nurses
- CMR Department
- Clarendon Wing, LGI, Leeds, LS1 3EX
- Email: cmrresearch@leeds.ac.uk
- Tel: 0113 392 5481 or 0113 392 5224