Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Continuous-flow left ventricular assist devices (LVAD) move blood from the left ventricle
(the largest chamber of the heart) to the aorta (the body's main artery) to help the heart
better meet the needs of the body and to improve survival for patients with advanced heart
failure (HF). The ability of the right ventricle (the large chamber on the right side of the
heart) to keep up with the improved blood flow following LVAD greatly effects how well a
person does following surgery. It is understood that a high pulmonary artery pressure
(pressure in the blood vessel that takes blood from the right side of the heart to the lungs)
measured before surgery, indicates that a higher risk of right heart failure exists after
LVAD implantation.
This is important because right heart failure after surgery is related to longer intensive
care unit (ICU) and hospital stays, increased morbidity (other health problems) including
organ failure and worse outcomes following heart transplant, and increased death rates.
Sildenafil (Revatio®) has been approved by Health Canada in the treatment of pulmonary
arterial hypertension (high blood pressure in the lungs) in patients with connective tissue
disease. Sildenafil has not yet been approved by Health Canada for the treatment of pulmonary
hypertension in heart failure. Sildenafil lowers blood pressure in the lungs and lessens the
workload of the right ventricle (the right side of the heart). The purpose of this study is
to determine if lowering blood pressure in the lungs, in heart failure patients at risk for
developing right heart failure after LVAD implant, lowers the incidence of right heart
failure, shortens ICU and hospital stays and reduces morbidity (other health problems) and
mortality (death rates).
This is an open label, single arm study. Everyone who participates in this study will receive
sildenafil before and after LVAD surgery. It is expected that 24 patients who are scheduled
to have LVAD implantation for advanced heart failure will be enrolled from 6 sites across
Canada. Participants will be followed in the study for about 2 months.