Researchers at Vanderbilt University Medical Center have been awarded a five-year, $4 million federal grant to test whether a personalized medicine strategy will improve outcomes for patients hospitalized with acute heart failure.
Each year 800,000 patients with acute heart failure are admitted to U.S. hospitals from emergency rooms. These patients are at high risk for prolonged hospital stays and death. The annual cost of treating acute heart failure in the United States is estimated to exceed $34 billion.
Diuretics are used in the vast majority of patients with acute heart failure to improve symptoms and lung congestion caused by fluid buildup. However, the optimal approach to diuretic therapy in patients hospitalized for acute heart failure remains poorly defined and contributes to prolonged inpatient stays, as well as unacceptably high death and readmission rates.
Furthermore, many patients do not respond to diuretics and about half of patients are discharged with persistent congestion. This can result in patients returning to the hospital soon after discharge and being readmitted for further heart failure therapy.
“There is an unmet need for a strategy to individualize diuretic therapy to improve decongestion, help patients feel better sooner, and avoid prolonged hospitalizations and early hospital readmission after discharge,” said the grant’s principal investigator, Sean Collins, MD, MSci, professor of Emergency Medicine.
Collins and his colleagues have demonstrated that low urinary sodium levels after initial diuretic dosing is associated with diuretic resistance and worse outcomes.
A pilot study conducted by the study team also suggests that long-term outcomes improve when spot (one-at-a-time) urinary sodium measurements are used to titrate, or adjust, to the most effective dose of diuretic. They are now going to further explore the use of urinary sodium to guide therapy.
The grant from the National Heart Lung and Blood Institute of the National Institutes of Health (HL155810) will enable the researchers to conduct a blinded, randomized clinical trial comparing their individualized approach to diuretic therapy guided by urinary sodium with standard treatment with intravenous “loop” diuretics.
“This study is particularly exciting because it is testing ways to make existing therapies more effective by leveraging real-time information about how individual patients respond to treatment,” said Chris Lindsell, PhD, professor of Biostatistics and Biomedical Informatics who is leading the Data Coordinating Center for the clinical trial.
“Tailoring care to the patient has the potential to save lives without having to add new treatments into the mix,” Lindsell said.
The researchers will look at differences in symptom improvement, time spent in the hospital and mortality over 30 days between these two strategies. They will also evaluate the impact of the two therapeutic strategies on novel kidney injury biomarkers.
The study will be conducted in the emergency rooms and inpatient floors at Vanderbilt University Hospital and the Nashville VA Medical Center.
Other collaborators include:
- Wesley Self, MD, MPH, Alan Storrow, MD, Ian Jones, MD, Jesse Wrenn, MD, and Karen Miller, Department of Emergency Medicine;
- Lynne Stevenson, MD, JoAnn Lindenfeld, MD, and Henry Ooi, MBBCh, MRCPI, Division of Cardiovascular Medicine;
- Marc Beller, Vanderbilt Health IT; and
- Zac Cox, PharmD, Lipscomb University.