The Transform-HF Study

This study is looking to answer a very important medical question: which type of water pill works best for patients with heart failure? To answer this question, the study will directly compare the effects of furosemide (also called lasix™) with the effects of torsemide (also called demadex) among patients with heart failure.

Why is this study being done?

Every year, over 6 million Americans are affected by heart failure, with about 1 million Americans being hospitalized for heart failure. When patients have heart failure, this can increase the amount of water and sodium (salt) the body holds onto. This extra fluid can lead to swelling and shortness of breath.

Medicines known as “water pills” (also called diuretic pills) are prescribed to help remove the extra fluid from the body due to heart failure. Two of the water pills most commonly ordered by doctors for patients are furosemide (lasix™) and torsemide (demadex™), with furosemide being the medicine more commonly ordered. Both medications are FDA approved and are widely available at pharmacies across the United States with a prescription.

Patients in the TRANSFORM-HF study have been diagnosed with heart failure and are taking a water pill as part of the treatment for their heart failure.  Currently, there is not enough information to tell us which water pill is best for patients with heart failure, furosemide or torsemide. This study is being done to compare these two medicines and to determine which is best for patients who have heart failure.

More than 6 million Americans are living with heart failure

How does the study work?

Patients with heart failure who are admitted to the hospital will be randomized (like the flip of a coin) to a diuretic (water pill) that is either furosemide (Lasix™) or torsemide (Demadex™). The study includes patients with either low ejection fraction (“weak hearts”) or those with normal ejection fraction (“stiff hearts”). Medication dose and frequency will be determine by the patient’s medical team. When patients are discharged from the hospital, they will go home with a prescription for the assigned water pill. Patients will follow-up as usual with their normal medical team but with the goal to use the assigned medicine as their water pill.

There are no in-person visits as part of this study and patients will continue to follow-up with their normal medical team as needed. Instead of in-person visits, patients in TRANSFORM-HF will receive telephone calls from Duke Clinical Research Institute (DCRI) at 30 days, 6 months and 12 months to ask questions about medication use, quality of life, and hospitalizations.

 

6000 heart failure will be randomized in a 1 to 1 ratio (like the flip of a coin) to either furosemide or torsemide. The primary endpoint is all-cause mortality. Secondary endpoints include all-cause mortality or hospitalization at 30 days and 12 months, total hospitalizations over 12 months, health-related quality of life over 12 months, and symptoms of depression over 12 months.

Which type of water pill works best for patients with heart failure?

Who? Where?

Who will be included?

About 6,000 hospitalized heart failure patients will be included in this study.

Who is doing the study?

The National Institutes of Health (NIH)/ National Heart, Lung, and Blood Institute (NHLBI) and the Duke Clinical Research Institute (DCRI) are working together to lead the study. The study director is Dr. Eric Velazquez, who works at Yale University. Several hospitals across the United States are participating in the study.

Where is the study being done?

Patients from all over the United States are being included!