Transform Ro 1 Advanced HF Ancillary Biomarker Study

Patients with heart failure are frequently treated with diuretics, including furosemide and torsemide, but it is not known if one is better than the other. The TRANSFORM-HF trial is studying if torsemide is superior than furosemide for reducing the endpoint of death or hospitalization, but is not designed to study why. This ancillary study seeks to measure proteins in the blood and urine to help explain the underlying mechanism for why patients who take one of these diuretics may have better outcomes than patients who take the other.

Clinical Information:

The ancillary study will address critical mechanistic questions by collecting serial bio specimens in a subset of patients enrolled in the TRANSFORM-HF trial. The study will describe how the trajectory of proteins and biomarkers clustered to multiple biologic roles are influenced by diuretic strategy overall and within important subgroups including gender, race, and baseline EF and determine the trajectory of renal function decline post HF hospitalization, estimate the effect of diuretic strategy on renal function and determine the association of renal function decline with urinary biomarker evidence of tubular injury.

Inova Fairfax Medical Campus
3300 Gallows Road
Falls Church, VA 22042

Inova Center for Personalized Health
8081 Innovation Park Drive, Suite 700
Fairfax, VA 22031

• Patient hospitalized (≥ 24 hours or over a change in calendar date) with worsening of chronic heart failure, or new diagnosis of heart failure AND meets 1 of the following criteria:
  • Has a left ventricular ejection fraction (EF) ≤ 40% within 24 months prior to and including index hospitalization by any method (with most recent value used to determine eligibility)
  • Has an elevated natriuretic peptide level (either NT-pro-B-type natriuretic peptide or B-type natriuretic peptide) during index hospitalization as measured by local laboratory
• Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with anticipated need for long-term loop diuretic use
• ≥ 18 years of age
• Willing to provide blood and urine sample at enrollment and follow-up
• Willing to participate in the TRANFORM-HF trial

• End-stage renal disease requiring dialysis therapy
• Inability or unwillingness to comply with the study requirements
• History of heart transplant or actively listed for heart transplant
• Implanted left ventricular assist device or implant anticipated < 3 months
• Pregnant or nursing women or women who are trying to conceive
• Malignancy or other non-cardiac condition limiting life expectancy to < 12 months
• Known hypersensitivity to furosemide, torsemide, or related agents

For additional information, please visit: https://clinicaltrials.gov/ct2/show/NCT04702958