drugset / Trial / NCT01571037

Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study

NCT01571037

NaSingle-groupOpen-labelTreatment

Summary

Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left ventricular assist device (LVAD) implantation and has been shown to adversely affect peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and post-operatively are limited. Inhaled milrinone has been shown in several small human studies to be safely tolerated and provide favorable effects on pulmonary hemodynamics. Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may provide pulmonary artery vasodilation and therefore improved RV function in patients with end stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation or as destination therapy. Specifically, we aim to: * demonstrate safety of inhaled milrinone in this patient cohort * demonstrate efficacy of inhaled milrinone in this patient cohort

Timeline

Start
2012-04-05
Primary completion
2013-02-01
Completion
2014-02-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Milrinone Small molecule 0.5 mg/ml Inhaled