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CHICAGO -- For patients with heart failure in recovered dilated cardiomyopathy (DCM), therapy withdrawal should be done cautiously, as improvement often signifies remission -- not permanent recovery, researchers reported here.

In the TRED-HF trial, there were 50 patients that withdrew from therapy, but only 44% met the primary endpoint of relapse of DCM within 6 months versus patients that continued treatment. reported Brian Halliday, MBChB, PhD, of Imperial College in London at the American Heart Association (AHA) annual meeting and in the.

Relapse of DCM meant reduction in left ventricular ejection fraction (LVEF) by >10% and to <50%; a rise in LV end-diastolic volume by >10% and to over the normal parameter; a two-fold increase in N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) and to >400 ng/L and clinical evidence of heart failure, the authors stated.

There are a range of outcomes for patients with DCM, and for many the disease tends to be relatively harmless. Many patients, especially those who wish to become pregnant or are very young, question if they must continue their treatment course for a lifetime. These treatments can be costly and reducing the number of unneeded prescriptions a patient takes might benefits their wellness, the investigators noted.

Some HF patients reach permanent DCM recovery, while others relapse when taken off treatment. There is limited research looking at treatment withdrawal for DCM patients, and more information is needed to develop clear guidelines, they stressed.

The researchers conducted "a pilot study to examine the effect of treatment withdrawal in patients with clinical, imaging, and biochemical evidence of recovery from dilated cardiomyopathy."

AHA discussant Jane Wilcox, MD, of Northwestern University Feinberg School of Medicine in Chicago stated that "The key implications of this study really lead to further questions about mechanisms for improvement."

In an accompanying , Wilcox, along with Clyde Yancy, MD, also of Northwestern, said the trial findings remind clinicians "that mechanisms of improvement after exposure to evidence­ based medical treatments, although well informed, have not been fully resolved. Other than LVEF, there are no biomarkers or clinical profiles that align with treatment responses."

Wilcox and Yancy urged clinicians to be more precise with their nomenclature -- patients whose ventricular function has been restored are less likely to have recovered ventricular function, but should be considered to have ventricular dysfunction in remission.

While this idea is not new, the current findings "now endorse the view that most patients with restoration of ventricular function as measured by an improved LVEF are in remission and have an indefinite indication for evidence­ based medical treatment without interruption," they stated.

Halliday's group evaluated 51 patients, from April 21, 2016 to Aug. 22, 2017, and- randomly assigned them to the treatment withdrawal group (n=25) and the continue treatment group (n=26). They enrolled patients from a network of hospitals in the U.K.

"After 6 months, 25 (96%) of 26 patients assigned initially to continue treatment attempted its withdrawal," the authors wrote. "During the following 6 months, nine patients met the primary endpoint of relapse" for a 36% Kaplan-Meier estimate of event rate (95% CI 20.6-57.8).

The researchers reported that none of the patients died in either group, but for the patients that withdrew from treatment, there were serious adverse events including hospital admission for non-cardiac chest pain, sepsis, and an elective procedure.

The authors acknowledged some study limitations, specifically "the power to examine the association between baseline characteristics and relapse was restricted by the number of participants," they wrote. "The study might also have been too small to identify differences in variables such as NT-pro-BNP, which appeared to lag behind the reduction in LVEF."

The results suggested that complete withdrawal of treatment should not be undertaken in this patient population, they noted. However, they pointed out that "Future work could identify patient subgroups who have permanent recovery of myocardial function for whom withdrawal is safe or for whom only some medications need to be continued in the long term."