Thank you for participating in the TRANSFORM-HF study! With your help, medical researchers are trying to determine which type of "water pill" (diuretic medication) works best for taking care of patients with heart failure. The information below explains your important role in the study.
Here is what happened after you signed the informed consent form:
While you were in the hospital:
We recorded some basic information about you, your medical history, and how you feel about your quality of life. We also had you fill out a patient contact form so we know the best way to contact you after you leave the hospital. You were then randomized (like the flip of a coin) to either torsemide or furosemide as your water pill and you were prescribed that water pill at time of discharge as treatment for your heart failure after you leave the hospital.
After you leave the hospital:
You will follow-up with your regular medical team as you normally would. For purposes of the study, you will receive phone calls from the study team, starting at about 30 days after you decided to be in the study, and then about every 6 months after that. You will receive at least 3 phone calls but no more than 6 (extending up to 30 months after you decided to be in the study). During these phone calls, a member of the study team will ask you questions about how you are feeling, if you have been back to the hospital for any reason, if you are still taking the water pill the study chose for you, and questions about your other medications.
What types of research will be done with my information?
How long will I be in the study?
see answers below
Can I quit before my part in the study is complete?
Will I be paid for being in the study?
see answers below
What am I being asked to do in this study?
You will follow-up with your regular doctors and medical teams as you normally would. You and your regular healthcare providers remain completely in charge of your medical care and medications, but we ask that you and your medical team try to use the type of water pill (torsemide or furosemide) the study picked for you, if at all possible. For the study, it is ok to change the dose or number of times per day you take the water pill as long as the type of water pill is the one the study picked for you. You have been given an information card for your wallet and other informational flyers – we ask that you bring these to your medical appointments and show your healthcare providers so they can learn about the study.
Are there costs to me for being in the study?
Who can I contact if I have more questions about the study?
see answers below
Frequently Asked Questions
WHAT TYPES OF RESEARCH WILL BE DONE WITH MY INFORMATION?
Research will be done to find out how the two water pills compare with each other for helping heart failure patients live longer, stay out of the hospital, and feel better. Research will try to find out if certain people with heart failure benefit from one water pill more than the other. Using the information collected, research may also help us to understand the way water pills affect the heart and body of patients with heart failure.
HOW LONG WILL I BE IN THE STUDY?
You will be in this study for at least 1 year after you enroll, but no more than about 30 months, total. Your first study visit will be done while you are in the hospital. All other study visits will be done by phone, with calls scheduled with you starting at about 30 days after you start the study, then every 6 months for up to about 30 months.
CAN I QUIT BEFORE MY PART IN THE STUDY IS COMPLETE?
Yes, you can. Taking part in this study is your choice at all times. No matter what you decide, now or in the future, it will not affect your usual medical care.
If you choose to end your participation in the study, you may contact the Duke Clinical Research Institute Call Center by phone (1-888-838-5171) or email (Transform_HFemail@example.com), or you can contact the study team members at the hospital where you were enrolled. You may choose to have different levels of participation as well. For example, you may allow the study to get information on your health and possible hospital stays but decide you do not want to receive any phone calls.
If for some reason your healthcare provider changes the type of water pill you are taking, or asks you to stop taking a type of water pill, you will still be allowed to stay in the study unless you ask us to take you out of the study.
WILL I BE PAID FOR BEING IN THE STUDY?
There are no payments made to you for participation in the study.
ARE THERE COSTS TO ME FOR BEING IN STUDY?
There are no costs to you for being in the study. You will be responsible for the cost of your water pill as you normally would, and if you have insurance that may help cover the cost of your water pill.
WHO CAN I CONTACT IF I HAVE MORE QUESTIONS ABOUT THE STUDY?
If you have more questions, you can call the study team members at the hospital where you were enrolled. You received the contact information for the hospital study team when you decided to be in the study.