Study Findings May Shift Treatment Paradigm for Acute Heart Failure

Roche announced an early termination of the Safety, Tolerability, and Efficacy of Rapid Optimization of Heart Failure (STRONG-HF) study in patients hospitalized for acute heart failure because the superior efficacy observed in the active arm of the study using the Elecsys NT-proBNP biomarker compared with usual standard of care made it “unethical” to continue with usual care.

NT-proBNP is a cardiac hormone that is released into the blood when the heart wall is stretched. The Roche Elecsys NT-proBNP test is an objective biomarker that aids in the diagnosis of individuals believed to have congestive heart failure. The test is also indicated for risk stratification of patients with acute coronary syndrome and congestive heart failure, as well as to help assess the risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.

According to the researchers, implementing the study’s strategy within routine clinical practice could significantly lower all cause deaths or heart failure readmissions and increase quality of life for more patients with condition compared to current practices.

"We are very excited about the positive outcome of this Investigator Initiated Study, which Roche supported, as it has the potential to bring about a paradigm shift in the management of heart failure patients,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release. “It also emphasises how diagnostic solutions like NT-proBNP, embedded in a therapeutic strategy, are an integral part of improving patient care.”

Acute heart failure is a significant contributor to morbidity and mortality among patients with heart failure. Individuals admitted for the condition have an elevated risk of readmission and death, especially in the first month post discharge. In a recent analysis, it was found that only 1% of patients with heart failure with a reduced ejection fraction are receiving the optimal dose of guideline-directed medical therapy.

The open-label, randomized, STRONG-HF assessed the safety and efficacy of early and rapid up-titration for optimization of heart failure therapies. This included guideline-recommended, frequent NT-proBNP measures and close follow-up of patients admitted to the hospital for acute heart failure. There were 1078 patients enrolled in the study at the time of termination for superior efficacy.

The results showed an absolute risk reduction of 8.1 % and a relative risk reduction of 34% in all-cause mortality or heart failure (HF) readmission 6 months post enrollment in the high-intensity care cohort (ARR 8·1%, p=0·0021; NNT = 12; RR 0·66; high intensity care compared with usual care. The data show the risk of all-cause mortality or hospital readmission was 15.2% lower in the high intensity care arm who used NT-proBNP to guide titration of oral heart failure drugs compared with 23.3% in the usual care cohort without routine NT-proBNP testing and frequent visits.

Further, quality of life was higher in patients in the high intensity care cohort (EQ-5D visual analog scale (VAS) 3·49 points higher in favor of high intensity care arm [p<0·0001]).

“The STRONG-HF study outlines that guideline-recommended therapies for heart failure can be safely up-titrated at the end of an acute heart failure admission, and after discharge, under strict follow-up and assessment of signs and symptoms of congestive heart failure, renal function, potassium and Roche Elecsys NT-proBNP,” Roche said in a press release.

Previous studies produced limited data on the optimal therapeutic approach for patients after an acute heart failure admission, including which medications should be prescribed, at which doses, and based on the follow-up the patients received, according to the study.

REFERENCE

STRONG-HF study results demonstrate clear benefits for acute heart failure patients. Roche. November 9, 2022. Accessed November 9, 2022. https://www.roche.com/media/releases/med-cor-2022-11-09