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Combination therapy plus LVAD not validated in multicenter trial
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ISHLT 31st Annual Meeting and Scientific Sessions
SAN DIEGO – Despite a previous single-center trial indicating sustained survival for patients with nonischemic dilated cardiomyopathy who were treated with a left ventricular assist device plus optimal medical therapy followed by clenbuterol, a new multicenter study showed that this combination treatment in the same population did not confer the same benefit on myocardial recovery.
For Keith D. Aaronson, MD, medical director of the Heart Failure Program at the University of Michigan in Ann Arbor, and study researcher, the study began with some skepticism about whether there was any potential for clinical recovery with this treatment in patients with chronic HF.
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“At this point, while I don’t know how much this [treatment] brings out recovery or who will recover, I have to concede that this is a real phenomenon worth pursuing clinically and certainly warrants further study,” Aaronson said in a presentation.
The five-center, US-based study included nonischemic dilated cardiomyopathy bridge-to-transplant patients (n=17; median age, 57 years) who had received HeartMate XVE (Thoratec) and target or maximum tolerated angiotensin receptor antagonist, beta-blocker, ACE inhibitor, digoxin and aldosterone antagonist therapy. Patients were then given clenbuterol and beta-1 selective betablockers for 3 months following either plateau in reverse remodeling or 16 weeks.
Researchers withdrew four patients due to complications before treatment with clenbuterol. Following 4 months of LVAD therapy, the remainder of patients received clenbuterol for a median of 7 months.
Among the 13 patients that entered phase II of the study, 12 had an adverse event, which included muscle spasms and pain, supraventricular tachycardia and sustained ventricular tachycardia requiring cardioversion. Of these 12, three had a reduction in clenbuterol dose.
According to data, at the start of clenbuterol usage, LV ejection fraction was 42.5%, which decreased markedly at 6 months (31%). However, at 18 months, LVEF rose to 45%. Overall, one of the 13 patients were explanted, while two of the 10 evaluable patients without device complication requiring study withdrawal had marked myocardial recovery.
Significant limitations of the study highlighted by Aaronson included the very small sample size as well as loss of patients due to complications unrelated to clenbuterol or study procedures. – by Brian Ellis
Disclosure: Dr. Aaronson has received grant and research support from Thoratec, HeartWare and Terumo.
For more information:
- Aaronson K. Featured Abstract #3. Presented at: ISHLT 31st Annual Meeting and Scientific Sessions; April 13-16, 2011; San Diego.
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