NEW YORK (Reuters Health) – In patients with chronic Chagas cardiomyopathy and severe heart failure, left ventricular ejection fraction (LVEF) isn’t improved after autologous bone marrow derived mononuclear cell (BMNC) transplantation, Brazilian researchers report.
In an April 20th online paper in Circulation, Dr. Antonio Carlos Campos de Carvalho of the National Cardiology Institute, Rio de Janeiro and colleagues note that the condition is treated as all other heart failure syndromes and therapy may include beta-blockers, diuretics, angiotensin-converting enzyme inhibitors and spironolactone.
When disease progresses, heart transplantation is one of the few options. However, cell transplantation is emerging as an adjunct to standard therapy and intracoronary injection of BMNCs has proved safe and feasible. There has also been an indication of improved heart function.
To investigate further, the researchers enrolled 234 patients aged 18 to 75 years, with LVEF of less than 35% despite optimal pharmacological therapy, and randomly assigned them to receive intracoronary injection of autologous BMNC or placebo. A total of 183 patients completed the study; most of the others were from centers that were excluded from the study for protocol violations.
In the BMNC group, trimmed mean LVEF increased from 26.1% at baseline to 28.9% at six months and 29.6% at 12 months. Corresponding proportions in the placebo group, from 26.1% at baseline, to 29.8% at six months and 31.3% at 12 months, were not significantly different.
Although the trial was not powered to detect between-group differences in mortality, the outcome was also similar, with 17 (18.9%) deaths in the BMNC group and 18 (19.4%) in the placebo group.
Quality-of-life scores also showed no significant differences between groups. This was also true of other outcome measures.
The researchers stress that “this intractable disease leaves patients with end-stage heart failure with no treatment option other than heart transplantation.”
And Dr. Campos de Carvalho said, in an email to Reuters Health, that the failure of the current trial “does not mean that new cell types, delivery routes, and disease stages should not be pursued.”