A month-long treatment regimen with a novel inhaled inorganic nitrate yielded no significant improvement in exercise capacity, daily activity, symptom severity, or quality of life, new results from the INDIE-HFpEF study suggested.
The study included 105 patients with heart failure with preserved ejection fraction (HFpEF), who were randomly assigned to receive either the inorganic nitrate medication or placebo, administered three times daily for four weeks. The primary study endpoint was the change in maximal exercise capacity, with secondary endpoints of change in daily activity levels, quality of life, and symptom severity.
The researchers reported no significant differences in either the primary endpoint or the secondary endpoints between the study groups. Some possible factors that may have influenced the negative results included patients adherence to a demanding medication regimen, and possible inadequate exposure time.
“We are disappointed that this treatment strategy failed to live up to the promise it had shown in preliminary studies,” lead investigator Barry A. Borlaug, MD, of the Mayo Clinic in Rochester, Minnesota, said of the results. “We need to redouble our efforts to find an effective approach to treating this patient population, which represents a huge unmet public health need.”
To read more about the INDIE-HFpEF trial, click here.