Outpatient Providers

Thank you for your interest in the TRANSFORM-HF study!  You may be caring for a patient enrolled in this important clinical trial.  Please read below to learn more about how the study works.

Loop Diuretics

Loop diuretics are a very common medication for heart failure patients. The most common types of loop diuretic are furosemide (Lasix™) (approximately 90% of use) and torsemide (Demadex™).  Despite loop diuretics being the cornerstone of symptomatic treatment for patients with heart failure, there have been no large definitive clinical trials to determine which loop diuretic is best.  Thus, while acknowledging that loop diuretics are a critically important class of medication for heart failure patients, the American College of Cardiology and American Heart Association heart failure guidelines do not give a specific recommendation on which loop diuretic is best to use. Given this unmet clinical need, the TRANSFORM-HF study was designed to be a prospective, randomized, comparative-effectiveness trial to definitively compare torsemide with furosemide in heart failure patients.  

My patient is having worsening heart failure and volume overload. How do I manage this while my patient is enrolled in TRANSFORM-HF?

FAQs
see answers below

My patient does not want to participate in the study anymore. What do I tell them?

FAQs
see answers below

I have a patient who is enrolled in the TRANSFORM-HF study. What do I do?

Great! Thank you for your help in this important study.  Your patient was enrolled in the study during a hospitalization for heart failure where they were randomized to either oral furosemide or torsemide as their loop diuretic therapy. After patients leave the hospital, there are no study-specific clinic visits as part of study follow-up and patients will follow-up with their normal care providers as they normally would.  Instead of office visits, patients will receive follow-up phone calls to assess for interval rehospitalizations, patient reported quality of life, and ongoing medication information. This is an unblinded clinical trial, so both the patient and you as their healthcare provider are both aware of which loop diuretic the patient was assigned.

As part of study, it is important that as many patients as possible remain on the assigned loop diuretic (torsemide or furosemide). However, patient care and safety always take top priority, so please manage patients as clinically indicated.

I think I need to stop my patient’s loop diuretic for some reason, such as hypovolemia, hypotension, worsening renal function, electrolyte abnormality, etc. Can I stop the assigned loop diuretic without the patient falling out of the study?

FAQs
see answers below

Here is how you can help:

  • If clinically appropriate, please use the study assigned loop diuretic for any loop diuretic prescribed to your patient.
  • We know that the dose and frequency of loop diuretic a patient needs can change frequently, as patients can have episodes of worsening volume overload or dehydration. Please manage the dose and frequency of loop diuretic as clinically necessary and as you normally would. From the study perspective, the key point is that anytime you prescribe a loop diuretic to your patient that you use the assigned medication, but the dose and frequency is up to you!
  • To confirm whether your patient was assigned to torsemide or furosemide, ask the patient to show you the study wallet card they received in the hospital. This card will confirm the assigned loop diuretic. Also, please ask your patient to show the other informational flyers they received about this study, as some of these were specifically meant for them to show their healthcare professionals.  If the patient did not bring any of these flyers, click here to view this information.
  • If the patient does not have their wallet card or there is any question on which loop diuretic they were assigned to, please email transform_hf@dm.duke.edu
    or contact the TRANSFORM-HF study coordinator at the hospital where the patient was enrolled.

Are patients in TRANSFORM-HF allowed to receive intravenous (IV) loop diuretics, like IV furosemide?

FAQs
see answers below

What happens if my patient gets hospitalized for heart failure or another reason, and the assigned loop diuretic is not given?

FAQs
see answers below

Frequently Asked Questions

My patient is having worsening heart failure and volume overload? How do I manage this while my patient is enrolled in TRANSFORM-HF

Patient care and safety take top priority so please manage these situations with that in mind. However, if clinically appropriate, please use the study assigned loop diuretic for any loop diuretic therapy the patient receives. Dose and frequency of the assigned loop diuretic can be changed as clinically necessary.  Here are some examples of potential treatment strategies for worsening heart failure/ volume overload:

Patient randomized to
FUROSEMIDE (Lasix™)
Patient randomized to
TORSEMIDE (Demadex™)
Consistent with study Change dose or frequency of furosemide Change dose or frequency of torsemide
Consistent with study Add thiazide diuretic, like metolazone Add thiazide diuretic, like metolazone
Inconsistent with study Stop furosemide and start torsemide or bumetanide Stop torsemide and start furosemide or bumetanide

I think I need to stop my patient’s loop diuretic for some reason, such as hypovolemia, hypotension, worsening renal function, electrolyte abnormality, etc. Can I stop the assigned loop diuretic without the patient falling out of the study?

Yes. Please stop the assigned loop diuretic if you feel clinically appropriate. From the study perspective, the key point is that if you re-start an oral loop diuretic at a later date that you choose to re-start the assigned loop diuretic.

Are other types of diuretics, such as thiazide diuretics (like metolazone) or aldosterone antagonists (like spironolactone) ok to use with loop diuretics for purposes of the study?

Yes. Please use these other diuretics with the assigned loop diuretic as clinically appropriate.

What happens if my patient gets hospitalized for heart failure or another reason, and the assigned loop diuretic is not given?

We understand that some patients in the study will have repeat hospitalizations and that medications frequently change during the course of a hospitalization.  Patients should be managed as they normally would during the hospitalization. That being said, we encourage continuation of the assigned oral loop diuretic therapy during a hospitalization if clinically appropriate.

However, the key point for study purposes is to ensure that, if the patient is prescribed a loop diuretic at hospital discharge, they are prescribed the assigned loop diuretic (unless clinically inappropriate). If you see a study patient in clinic who had their loop diuretic switched during a recent hospitalization, we ask that you switch them back to the study assigned loop diuretic if clinically appropriate.

Are patients in TRANSFORM-HF allowed to receive intravenous (IV) loop diuretics, like IV furosemide?

Yes. More than 90% of patients hospitalized or visiting the emergency department for heart failure in the United States receive an IV loop diuretic.  We understand that patients enrolled in the study will have periods of worsening heart failure where use of IV loop diuretics is needed. For purposes of the study, the key point is that when the patient is back to receiving exclusively oral loop diuretics they receive the study assigned loop diuretic (unless clinically inappropriate).

If I switch my patient to a different loop diuretic other than the specific one assigned, or permanently discontinue my patients assigned loop diuretic, is the patient still in the study?

Yes. Patients will remain in the study unless they specifically contact the study team to quit the study.  Regardless of whether patients are taking the assigned loop diuretic, the study team will follow all enrolled patients through phone calls and review of medical records.

My patient does not want to participate in the study anymore. What do I tell them?

If a patient chooses to end participation in the study, they may contact the Duke Clinical Research Institute study team by phone (1-888-838-5171) or email (Transform_HF-followup@dm.duke.edu), or the study coordinator at the hospital where they were enrolled. Patients received the contact information for the enrolling hospital coordinator at time of their enrollment. It is important to remind patients that they may choose to have different levels of participation as well. For example, they may allow the study to get information on their health and possible hospital stays but decide they do not want to receive any phone calls.

Do I need to fill out any paperwork, check any labs, or do any other activities for my patient enrolled in TRANSFORM-HF?

No. Please manage your patient (including ordering blood work) as per usual care, with exception to trying to use the study assigned loop diuretic as clinically appropriate.

I am not very familiar with torsemide or furosemide. What are the available doses and how are these medicines generally prescribed? What are the potential side effects of torsemide and furosemide?

Both torsemide and furosemide are both FDA approved and widely available medications. Both medications are within the standard-of-care for management of patients with heart failure. Their side effect profiles are relatively similar and include electrolyte abnormalities, hypotension, dehydration, hearing problems/ringing in the ears, and worsening renal function.  For more specific information on the dosing, contraindications, adverse reactions, safety monitoring, and other information, click here to learn more about torsemide and click here to learn more about furosemide.