- Two drugs that showed promise for improving kidney function in small trials didn’t benefit acute heart failure patients with kidney dysfunction in a larger study.
- Neither low-dose dopamine nor nesiritide increased urine production or improved kidney function in acute heart failure patients also taking diuretics.
DALLAS — Two drugs that improved kidney function in small studies didn’t benefit acute heart failure patients with kidney dysfunction in a larger study presented as a late-breaking clinical trial at the American Heart Association’s Scientific Sessions 2013.
Previous small studies have suggested that low-dose dopamine or nesiritide could improve kidney function and reduce fluid overload by increasing urine production in patients hospitalized for acute heart failure.
In the Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE AHF) Trial randomized trial, researchers analyzed data on 360 hospitalized acute heart failure patients with renal dysfunction. They found that neither drug was better than placebo on top of standard care including diuretics at increasing urine volume or improving levels of serum cystatin-C, a marker of kidney function.
“We performed this study because both drugs are already available and there is currently no FDA-approved therapy for enhancing renal function in acute heart failure.” said Horng Chen, M.D., professor of medicine at the Mayo Clinic in Rochester, Minn.
Proper kidney function and adequate urination to get rid of excess fluid from the body is important for people with acute heart failure because fluid retention increases stress on blood vessels and forces the heart to work harder to maintain adequate blood circulation.
The majority of heart failure patients at some stage of the disease develop some degree of renal dysfunction. Conversely, the prevalence of heart failure increases greatly as kidney function deteriorates. The risk is as high as 70 percent for those with end-stage renal disease, according to the National Kidney Foundation.
“There was a suggestion of differential responses to the two study drugs in subsets of patients,” Chen said. However, the overall effect wasn’t significantly different.
“Acute heart failure patients are a very diverse group, with complex features based on blood pressure and how well the heart functions (i.e. ejection fraction). Future studies of AHF should evaluate therapies based on these important but targeted subsets,” he said. “There is a need for therapies that can improve kidney function in patients with acute heart failure. However, for now, this therapy continues to remain evasive and continued research is necessary.”
Co-authors are Barry A. Borlaug, Kevin J. Anstrom, G. Michael Felker, Michael M. Givertz, Anita Deswal, Bradley A. Bart, Lynne W. Stevenson, Jean L. Rouleau, Eileen O’Meara, Martin M. LeWinter, David A. Bull, Josef Stehlik, Marc J. Semigran, Steven R. Goldsmith, Elizabeth O. Ofili, Christopher M. O’Connor, W.H. Wilson Tang, Randall C. Starling, Javed Butler, David J. Whellan, Kenneth B. Margulies, Thomas P. Cappola, Marvin A. Konstam, Douglas L. Mann, Victor Davila-Roman, Steven E. McNulty, Eric J. Velazquez, Kerry L. Lee, Monica R. Shah, Adrian F. Hernandez, Eugene Braunwald, Margaret M. Redfield; NHLBI Heart Failure Clinical Research Network. Disclosures
The National Heart, Lung, and Blood Institute funded the study.
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Note: Actual presentation is 11:07 a.m. CT/12:07 p.m. ET Monday, Nov. 18, 2013 in Hall E.