Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Status:
Completed
Trial end date:
2018-05-10
Target enrollment:
Participant gender:
Summary
Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening
cardiovascular disorder, characterised by marked symptomatic limitation and frequent
hospitalization. It is particularly prevalent in older individuals (up to 10% of the
population) and it has become the most common cause for hospitalization in people >65yrs. As
such it is also one of the leading consumers of healthcare spending. Recurrent
hospitalization is frequently due in significant part to the lack of viable therapeutic
options for severe HF. During hospital admission, medications through a drip to give through
a vein (intravenous therapy), is required to improve heart pumping capacity (such as
milrinone).They are frequently used and in many cases prolonged treatment periods of
intravenous therapy are required. In a growing number of cases, there is a need to continue
this treatment at home, however this is particularly costly and often complicated by
intravenous line infection. As such there is an expanding need for therapeutic options in
patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid
release form of oral milrinone were examined, however these studies demonstrated adverse
effects due to its quick release.
This study aims to determine the safety and tolerability of slow release oral milrinone in
advanced HF patients with no further clinical option and to evaluate its effects on HF
status.